Design of

Biomedical
Devices
Module 3-Class-11 Design Verification,
Product validation and Design Transfer
 Product Development
• A product development process ensures that the design, development, and transfer of a new
or modified medical device will result in a product that is safe, effective, and meets user
needs and intended use requirements. As shown in Figure 6.1, design controls begin with the
approval of product requirements. Product requirements include the needs of the users and
patients and intended use of the device. A design and development plan is developed to
describe the design and development activities. The product requirements are converted
into technical design inputs (System Requirements Specification) that serve as a basis for the
design of a medical device. Iterations of the design process result in design outputs that are
verified against the design inputs to ensure that the design outputs adequately address the
technical design inputs. The finished device is validated to ensure that all product
requirements have been addressed. Final product and process specifications are transferred
to production. In the course of the design process, documentation pertaining to the design
of the finished device is maintained in a design history file (DHF). Changes to the device
design are managed and controlled both prior to and after design transfer until retirement.
Risk management is performed simultaneously with device design and development. Formal
design reviews are conducted at appropriate points to evaluate the adequacy of the design
to fulfill all requirements.
6.1 PRODUCT REQUIREMENTS
The product concept must be documented. This can range from a brief description
for products similar to existing ones to a formal document, such as a marketing
requirements document, for new and complex products.Product requirements
include the needs of the users and patients and address the intended use of the
device. They also include the following requirements, if applicable:
• User/patient/clinical performance characteristics,• Privacy and security,• Safety,•
Regulatory,• Quality, •Reliability, Compatibility with accessories/auxiliary devices or
products Compatibility with the intended environment,• Human factors,• Physical
characteristics,• Sterility, Manufacturability,• Serviceability,• Labeling, packaging,
storage,• Requirements for intended markets (domestic or international)
The types of information described may come from a variety of sources such as
market research studies, customer complaints, field failure analysis, service records,
regulatory needs, user interviews, and customer satisfaction analysis. Input sources
used shall be documented. Requirements that are essential to the quality, safety,
and proper function must be identified. Product requirements are reviewed,
approved, and documented in the DHF.
6.2 DESIGN AND DEVELOPMENT PLANNING
• Each product program must establish and maintain a plan(s) that
describes or references the design and development activities and defines
responsibility for implementation. It identifies and describes the
interfaces with different groups or activities that provide, or result in,
input to the design and development process. The design and
development plan is reviewed, updated, and approved as the design and
development of a product evolves. The design and development plan
describes how the different design control requirements are to be met. It
includes all major activities, design deliverables, responsibilities,
resources, and associated timelines for the development of a product.
The program team creates the design and development plan and reviews,
updates, and approves the plan as design and development evolves. The
design and development plan resides in the DHF, and any changes made
to the plan also reside in the DHF.
• 6.2.1 Design and Development Plan
• The following elements are addressed, if applicable, in the design and development
plan. The applicability of these elements is determined by the program team, and
justification is provided for elements deemed not applicable.
• 6.2.1.1 Program Goals
• High-level goals and objectives of the product are described, that is, what is to be
developed and other considerations that communicate the size, scope, and complexity
of the product development project.
• 6.2.1.2 Design and Development Elements
• Design and development elements refer to different categories of activities performed
in the design of a medical device from design inputs through design transfer to
manufacturing and service. The design and development plan describes the different
elements including their scope and planned approach to fulfill the requirements of
each element. The timelines for the activities associated with the different elements
are incorporated in the design and development schedule. Required design and
development elements include the following:
• 6.2.1.3 Organizational and Key Interfaces
• Identify the key individuals/functions responsible for performing the design and development
tasks,including cross-functional program team members and external resources, such as suppliers,
contractors,or partners. At a minimum, define the roles for research and development (R & D),
marketing,manufacturing, quality, reliability, regulatory, and service.
• 6.2.1.4 Deliverables and Responsibilities
• Identify the design control deliverables for the product program and indicate the personnel responsible
for completing them. The deliverables to be addressed are dependent on the size, scope, and complexity
of the product program and must be defined by the program team leader and program team.
• 6.2.1.5 Design and Development Schedule
• Based on the size, scope, complexity of the product program, the design and development elements,and
the list of deliverables, prepare a design and development schedule. The schedule is specified at the level
of detail necessary for carrying out major activities, completing program deliverables,and addressing
design control requirements. Identify these activities, deliverables, the responsible individual/function,
resources required, and the associated due dates. Indicate which activities are concurrent, sequential,
and dependent on other activities. Identify the major milestones and formal design reviews.
• 6.2.1.6 Approval of Design and Development Plan
• The plan is completed and approved by the program team prior to the commencement of detailed
design.
• 6.2.1.7 Incorporation of Updates to Design and Development Plan
• Changes to the design and development plan are reviewed and approved at key milestones as
determined by the program team. The design and development plan identifies the number and timing of
• 6.3 SYSTEM REQUIREMENTS SPECIFICATION
Product requirements are translated into the system requirements specification that specifies what the design must do to an
engineering level of detail. Inputs from results of risk management are included.
• The system requirements specification includes the following types of requirements:
• Functional requirements: these requirements specify what the device does, focusing on the operational capabilities of the
device and processing of inputs and the resultant outputs.
• Physical and performance requirements: these requirements specify how much or how well the design must perform,
addressing such issues as speed, strength, size, weight, response times, accuracy, precision, limits of operation, device safety,
reliability, and so forth.
• Interface requirements: these requirements specify characteristics that are critical to compatibility with external systems
(including user and/or patient interface).
• System architecture: these requirements specify relationships among logical functions,physical systems/subsystems, and
interfaces.
• Software requirements (if applicable): these requirements specify product functionality to be implemented through software
and the functional, performance, interface, and safety requirements for the software subsystem(s).
Where appropriate, the system requirements specification should include additional design details in areas such as
specification limits and tolerance, risk management, toxicity and biocompatibility, electromagnetic compatibility (EMC),
human factors, software, chemical characteristics, reliability,regulatory requirements, manufacturing processes, service
design requirements, and testing. If the design logically decomposes into subsystems, the system requirements specification
may be used to generate subsystem-level requirements. Traceability of the system requirements specification to product
requirements and design outputs is maintained. Requirements that are essential to quality, safety, and proper function are
identified. Incomplete, ambiguous, or conflicting requirements are identified and resolved using the following mechanism:
• The program team reviews design inputs to identify and resolve incomplete, ambiguous,or conflicting requirements.
• Any remaining incomplete, ambiguous, or conflicting requirements are addressed in a formal design review.
The system requirements specification is reviewed, approved, and documented in the DHF.
• 6.4 DESIGN INPUT
• Each product program must establish design inputs to ensure that design requirements relating to a device are appropriate and
address the intended use of the device, including the needs of the user and patient. There should be a mechanism for addressing
incomplete, ambiguous, or conflicting requirements. The design input requirements are documented, reviewed, and approved by a
designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, is
documented.
• Each product program establishes product requirements. Product requirements include the needs of the users and patients and
intended use of the device. Product requirements are translated into technical design inputs that are specified at an engineering
level of detail.
• Product requirements and the system requirements specification obtained from the translation of product requirements constitute
design input for the product program. Traceability is maintained to ensure that product requirements are linked to the
corresponding system requirements specification and design outputs.
• 6.4.1 Product Requirements
• The product concept is documented, and the higher-level product requirement is codified. This can range from a brief description
for products similar to existing ones to a formal document, such as a marketing requirements document, for new and complex
products. Product requirements include the needs of the users and patients and address the intended use of the device.
• They also include the following requirements, if applicable:
• User/patient/clinical performance characteristics,• Privacy and security,• Safety,• Regulatory,• Quality,• Reliability,• Compatibility
with accessories/auxiliary devices or products,• Compatibility with the intended environment,• Human factors,• Physical
characteristics,• Sterility,• Manufacturability,• Serviceability,• Labeling, packaging, storage,• Requirements for intended markets
(domestic or international)
• The types of information described above may come from a variety of sources such as market research studies, customer
complaints, field failure analysis, service records, regulatory needs, user interviews, and customer satisfaction analysis. Input
sources used are documented. Requirements that are essential to quality, safety, and proper function are identified. Product
requirements are reviewed, approved, and documented in the DHF.
• 6.5 DESIGN OUTPUT
Design outputs are the results of the design effort. Initial design activities result in
intermediate design outputs. As design and development progresses, intermediate
design outputs evolve into final design outputs that form the basis of the device
master record (DMR).
• 6.5.1 Intermediate Design Output
• Intermediate design outputs are deliverables that define and characterize the design.
The following intermediate design outputs are created and recorded in the DHF as
applicable:
• Preliminary design specifications
• Models and prototypes
• Software source code
• Risk analysis results
• Traceability documents
• Biocompatibility and bioburden test results
• Other intermediate design outputs as appropriate
• 6.5.2 Final Design Output
• Final design outputs form the basis of the DMR, are recorded in the DHF, and shall include the
following elements:
• Device specifications
• Device drawings
• Component
• Assembly
• Finished device
• Composition, formulation, component specifications
• Subassembly specifications (if applicable)
• Component and material specifications
• Product configuration documents
• Parts list
• Bill of materials
• Software specifications (if applicable)
• Software machine code, such as a diskette or master EPROM
• Production process specifications
6.5.2 Final Design Output-contd…

• Critical production process specifications

• Equipment specifications
• Production methods and procedures
• Test protocols
• Work instructions
• Production environmental specifications Quality assurance procedures and specifications
• Acceptance criteria
• Purchasing and acceptance requirements
• Quality assurance equipment to be used
• Packaging and labeling specifications including methods and processes used
• Installation, maintenance, and servicing procedures and methods
• Installation instructions
• Service and maintenance instructions
• 6.6 FORMAL DESIGN REVIEW
• Formal documented reviews of design results should be planned and conducted at appropriate
stages of device design and development. Participants at these reviews include representatives of
all functions concerned with the design stage being reviewed and an individual(s) who does not
have direct responsibility for the design stage being reviewed, as well as any necessary specialists.
The results of these reviews are documented in the DHF and include identification of the design,
date, and individual(s) performing the review.
Formal design reviews are performed at major decision points or milestones in the design
process as specified by the design and development plan. They are intended to be a systematic
assessment of design results and to provide feedback to designers on existing or emerging
problems. Each formal design review must ensure that design outputs meet design inputs. They
may also be used as a “stage-gate” session where continued development is or is not continued.
• 6.6.1 Action Tracking and Issue Resolution
• Action items identified in formal design reviews are tracked to completion. Objective evidence of
completion is documented. Resolution of issues may involve a design change, a requirements
change, and/or analysis justifying no action. The program team is responsible for ensuring that all
issues and differences identified during the formal design review are resolved. Unresolved issues
are escalated to management for resolution, guidance, or additional resources.
• 6.7 DESIGN VERIFICATION
• Design verification is performed to confirm that the design output meets design input
requirements. The results of design verification are documented in the DHF and include the
identification of the design, test methods, date, and individual(s) performing the verification.
• 6.7.1 Design Verification Plan
• Plans for subsystem- and system-level verification activities need to be developed. Typically,
subsystem- level verification activities, if applicable, are performed before system-level
verification activities. The plan identifies the timing and types of verification activities to be
performed, the personnel performing the activities, and equipment to be used. Design
verification includes the following:
• Verification of requirements (system and subsystem level where appropriate)
• Verification of labeling, packaging, on-screen displays, printouts, and any other similar
Specifications
There must be confirmation that acceptance criteria have been established prior to the
performance of verification. As appropriate, necessary statistical techniques to confirm the
acceptance criteria must be identified.
Traceability is maintained between design outputs, their corresponding design inputs, and
verification activities to confirm that design outputs meet the system requirements specification.
Verification plans must be reviewed and approved.- Contd..
• 6.7.2 Design Verification Test Methods
• Test and inspection methods (protocols/scripts/procedures) for design are
developed, documented, and approved before use. Verification methods include
the following, if applicable:
• Integration testing
• Functional testing
• Accuracy testing
• System and subsystem performance testing
• Software testing such as unit/module, integration, system-level, and regression
testing
• Package integrity tests
• Biocompatibility testing of materials
• Bioburden testing of products to be sterilized(Bioburden testing is the
activity required to determine the microbiological quality or
cleanliness of a test unit)
Verification may be done by analysis where testing is not appropriate or practical,
Design Verification Test Methods-Contd.
• Tolerance analysis
• Worst-case analysis of an assembly to verify that components are derated
properly and not subject to overstress during handling and use
• Thermal analysis of an assembly to assure that internal or surface
temperatures do not exceed specified limits
• Fault tree analysis of a process or design
• Failure modes and effects analysis of a process or design
• Finite element analysis
• Software source code evaluations such as code inspections and walk-throughs
• Comparison of a design to a previous product having an established history of
successful use
• Clinical evaluation analysis
6.7.2 Design Verification Test Methods- Contd..

Test methods are based on generally acceptable practices for the technologies employed in similar
products, such as compendia methods (standardized methods)(e.g., American Society for Testing
Materials [ASTM], International Electrotechnical Commission [IEC], Institute of Electrical and
Electronic Engineers [IEEE], National Institute of Standards and Technology [NIST]). Test methods
include defined conditions for testing. The test equipment used for verification must be
calibrated and controlled according to quality system requirements. Repeatability and
reproducibility of test procedures are determined. Technical comments about any deviations or
other events that occur during testing shall be documented.

6.7.3 Design Verification Report

A design verification report summarizes the results of verification activities. Detailed verification
results, such as original data, are contained or referenced in the report. The design verification
report and referenced documents are included in the DHF. Documentation of the results includes
identification of the design, method(s), date, and the individual(s) performing the
verification.Review and approve verification results to ensure that acceptance criteria have been
met and all discrepancies identified by verification are resolved.
6.8 DESIGN VALIDATION
Design validation is performed to ensure that the device design conforms
to user needs and intended uses. Design validation is performed under
defined operating conditions on initial production units, lots, batches,
or their equivalents and shall include testing of production units under
actual or simulated use conditions. Design validation includes software
validation and risk analysis, where appropriate.The results of validation
are documented in the DHF and include the identification of the design,
test methods, date, and individual(s) performing the validation.
• 6.8.1 Design Validation Plan
The design validation plan identifies the timing and types of validation activities to be performed, performance
characteristics to be assessed, personnel performing the tests, and equipment to be used in validating the
device.
Design validation includes the following, if applicable:
• Software validation
• External evaluations
• Process validation
• Risk analysis
• Validation of labeling and packaging
There must be confirmation that acceptance criteria have been established prior to the performance of
validation. As appropriate, identify necessary statistical techniques to confirm the acceptance criteria.
Validation needs to be performed on initial production units, lots, batches, or their equivalents and done under
actual or simulated use conditions. Where equivalent materials are used for design
validation, such materials must be manufactured using the same methods and specifications to be used for
commercial production. Justification needs to be provided to establish why the results are valid and must
include a description of any differences between the manufacturing process used for the equivalent device and
the process intended to be used for routine production. Validation must be complete before commercial
distribution of the product.
Traceability must be maintained between design outputs, their corresponding design inputs, and validation
activities to confirm that design outputs meet product requirements. Validation plans are reviewed for
appropriateness and completeness and to ensure that user needs and intended use(s) are being addressed.
6.8.2 Design Validation Test Methods
Test and inspection methods (protocols/scripts/procedures) for design validation must be developed,documented, and
approved before use. Validation methods include the following, if applicable:
• Simulated use testing
• Testing confirming product data sheets, users’ manual, product labels, and user interface
screens
• Safety testing
Validation may be done by analysis where testing is not appropriate or practical, such as the
following:
• Historical comparisons to older devices
• Scientific literature review
• Failure modes and effects analysis of a design or process
• Workload analysis
• Alternative calculations
• Auditing design output
• Comparison of a design to a previous product having an established history of successful use
Validation is performed according to a written protocol that includes defined conditions for testing and simulations of
expected environmental conditions such as temperature, humidity, shock, and vibration, and environmental stresses
encountered during shipping and installation.
The test methods identified in the plan are based on generally acceptable practices for the technologies employed in
similar products. The test equipment used for validation is calibrated and controlled according to quality system
requirements. Repeatability and reproducibility of test procedures is determined.
Design Verification vs. Design Validation For Medical Devices: What’s the Difference?
What is Design Verification?
Design Verification refers to the process where you confirm through examination and evidence
that the final design of your product meets the requirements of the intended consumer. During
design verification, the goal is to ensure that your design inputs match your design outputs.
Verification not only demonstrates that the product will do what it’s supposed to do, but that it
does it in the way the design anticipates. In addition, developers will confirm if the design
complies with the necessary requirements, applicable regulations, specifications, and conditions
set forth in the design plans and assembly instructions.
Design Verification Example
Let’s imagine we’re building a portable oxygen concentrator. This device extracts oxygen from
the surrounding air and turns it into condensed oxygen for the patient to breathe. During Design
Verification, the following questions can be asked to define specific product requirements:
• How long does the battery need to last?
• How does the device need to be charged?
• What is the maximum amount of oxygen that can be taken in by the patient?
• What conditions will the patient encounter while they are mobile?
• What regulatory standards need to be met?
• What is Design Validation?
• Design Validation is a testing process by which you prove that the device you’ve built
works for the user as intended. The FDA states that design validation is “establishing by
objective evidence that device specifications conform with user needs and intended
use(s).” Design Validation is performed to provide evidence that the process consistently
produces a result that meets its predetermined specifications. While completing the
medical device design validation process, it is important to test the built device in a real-
world setting to account for all the possible complications and further ensure that the user
needs are met.
• Design Validation Example
• Returning to our portable oxygen concentrator example, first, we must define our user
needs. We know that the patient wants to be able to move around with ease while using
the oxygen concentrator. Specifically, the user wants to be able to use the device in all
areas of travel, such as air travel. A user need, for example might look like the following:
• User Need: The oxygen concentrator is suitable for portable use in an airplane.
• Validation Test Suite: Test that the oxygen concentrator can be moved around easily with
the user in a smaller space with 20 different patients
• Validation Test Suite: Test that the oxygen concentrator operates within its specifications
while moving up and down small aisles, compact rooms (airplane bathrooms), and
different levels of altitudes
• Summary of Differences: Design Verification vs Validation
• Design Verification and Validation (DV&V) answer two different questions. Design
Verification answers: Did you design the device right? While Design Validation answers:
Did you design the right device?
• Validation differs from verification in that validation focuses on performing specific tests
to demonstrate that the device works for the end user properly. While verification
focuses on verifying device specifications and confirming that the specific requirements
of the design correlate properly to its functionality and usability.
6.8.3 Design Validation Report
A design validation report summarizing the results of validation activities
is developed. Detailed validation results, such as original data, are
contained or referenced in the report. The design validation report and
referenced documents are included in the DHF.
Documentation of the results includes identification of the design,
method(s), date, and the individual(s) performing the validation.
Validation results are reviewed and approved to ensure that
acceptance criteria have been met and all discrepancies identified by
verification are resolved.
 VALIDATION LIFE CYCLE
VALIDATION LIFE CYCLE
1.PLANNING PHASE-
a.Objective Definiton b.Validation
plan.

2. Design and Development Phase:

a.Design Inputs,b.Design Outputs and c.Design
verification.

3. Validation Protocol Preparation:

a.Protocol development and b.Protocol approval.

4. Validation Testing:
a.Execution and b.Data collection.

5. Data Analysis and Reporting:

a.Data Analysis and b.Report generation.

6. Validation Review and Approval:

a.Cross functional review and b.Approval process.

7. Post-Validation Activities:
a.Corrective actions and b.Documentation update.

8. Regulatory Submission (if applicable):

a.document preparation and b.Regulatory compliance.

9. Production and Commercialization:

a.Transition to production and b.Market monitoring

10. Periodic Revalidation:

a.Risk assesment and b.Revalidation activities
The validation life cycle
The validation life cycle of a medical device encompasses various stages and processes to ensure that the device meets
regulatory requirements, performs as intended, and is safe for use. Here's a detailed description of each phase:
1.Planning Phase:
• Objective Definition: Define the validation objectives based on regulatory requirements, user needs, and product
specifications.
• Validation Plan: Develop a comprehensive validation plan that outlines the scope, approach, resources, responsibilities, and
timelines for validation activities.
2. Design and Development Phase:
• Design Inputs: Gather and document user requirements, risk analysis, and regulatory requirements to create design inputs. –
• Design Outputs:** Develop design outputs such as drawings, specifications, prototypes, and software code. –
• Design Verification:- Perform design verification activities to ensure that the design outputs meet the specified design inputs.
3. Validation Protocol Preparation:
• Protocol Development: Create validation protocols detailing the testing methods, acceptance criteria, sample size, and test
equipment.
• Protocol Approval: Obtain approval for validation protocols from relevant stakeholders, including regulatory authorities if
required.
4. Validation Testing:
• Execution: Conduct validation testing according to the approved protocols, using appropriate methods and equipment. –
• Data Collection: Record and document all test data, observations, deviations, and any corrective actions taken during
testing.
5. Data Analysis and Reporting:
• Data Analysis: Analyze the validation data to determine if the device meets the predetermined acceptance criteria and
performance standards. –
• Report Generation:Prepare a validation report summarizing the testing results, conclusions, deviations, corrective actions,
Validation life cycle.contd..
6. Validation Review and Approval:
• Cross-Functional Review: Review the validation report with cross-functional teams, including quality assurance, regulatory affairs, and
management. –
• Approval Process: Obtain approval and sign-off on the validation activities from relevant stakeholders, ensuring compliance with regulatory
requirements.
7. Post-Validation Activities:
• Corrective Actions: Implement any corrective and preventive actions identified during validation testing or review processes. –
• Documentation Update: Update documentation, including the Device Master Record (DMR), with validated design specifications and
production processes.
8. Regulatory Submission (if applicable):
• Documentation Preparation: Prepare and submit required documentation, including the validation report, to regulatory authorities for approval
or clearance. –
• Regulatory Compliance: Address any feedback, requests for additional information, or queries from regulatory agencies to ensure compliance
with regulations.
9. Production and Commercialization:
• Transition to Production: Transition the validated design and processes to production, ensuring that manufacturing processes adhere to
validated parameters. –
• Market Monitoring: Monitor the device's performance in the market, gather user feedback, and track any post-market surveillance data for
continuous improvement.
10. Periodic Revalidation:
• Risk Assessment:. Conduct periodic risk assessments to identify any changes or updates that may require revalidation. –
• Revalidation Activities: Plan and execute revalidation activities as needed to maintain the device's safety, efficacy, and regulatory compliance
over its lifecycle.
Throughout the validation life cycle, documentation, traceability, and adherence to regulatory standards are crucial to ensuring the quality, safety,
and
effectiveness of the medical device. Collaboration among multidisciplinary teams, rigorous testing, and ongoing monitoring are key elements in
achieving successful validation and product development.
6.9 DESIGN TRANSFER
Design transfer ensures that the device design is correctly translated
into production specifications and that the finished device is
successfully transferred from design to production and service.
Production specifications ensure that devices are repeatedly and
reliably produced within product and process capabilities.
Design Transfer Process
The design transfer process for a medical device typically involves several steps, ensuring a smooth transition from the design phase to
manufacturing and production. Here are the key steps involved:
1. Documentation Review: Conduct a thorough review of all design documentation, including design files, specifications, drawings, and any
associated documentation, to ensure completeness and accuracy.
2. Design Verification and Validation: Verify and validate the design to ensure it meets the intended requirements and specifications. This involves
conducting testing, inspections, and analyses to confirm the design's functionality and performance.
3. Manufacturing Process Development: Develop the manufacturing processes necessary to produce the medical device. This includes establishing
procedures for manufacturing, assembling, and testing the device, as well as identifying any necessary equipment, tools, or materials.
4. Design Transfer Plan: Create a comprehensive plan outlining the steps, timelines, and responsibilities for transferring the design to manufacturing.
This plan should address all aspects of the transfer process, including design documentation, process validation, and quality assurance.
5. Process Validation: Validate the manufacturing processes to ensure they consistently produce devices that meet the design specifications. This
may involve conducting process capability studies, stability testing, and other validation activities.
6. Supplier Qualification: Identify and qualify suppliers for the components and materials required in the manufacturing process. This involves
evaluating their capabilities, quality systems, and adherence to regulatory requirements.
7. Design Transfer Execution: Execute the design transfer plan, which includes transferring the design documentation, manufacturing processes, and
specifications to the production team. This may involve training manufacturing personnel, updating standard operating procedures, and ensuring
proper communication between design and manufacturing teams.
8. Risk Management: Perform a risk assessment to identify and mitigate any potential risks associated with the design transfer process. This includes
assessing risks related to quality, safety, and regulatory compliance.
9. Regulatory Compliance: Ensure that the design transfer process complies with relevant regulatory requirements and standards, such as those set
forth by the FDA or other regulatory bodies. This may involve submitting necessary documentation and obtaining regulatory approvals or
certifications.
10. Post-Transfer Activities: Monitor the production and performance of the medical device after the design transfer to ensure its continued
compliance with specifications and quality standards. This includes ongoing quality control, monitoring feedback from users, and implementing
any necessary design or process improvements.
It's important to note that the design transfer process may vary depending on the specific device, regulatory requirements, and company practices.
Working closely with regulatory experts, quality assurance teams, and manufacturing professionals is crucial for a successful design transfer.
Design Transfer
System Testing.
System testing in medical devices verifies that all components function correctly as a
complete, unified whole, ensuring the device meets specifications and is safe and effective
for patient use.
What is System Testing?
• Comprehensive Evaluation:
System testing evaluates the entire medical device system, including software, hardware,
and any interfaces, to ensure they work together as intended.
• Verification, Not Just Validation:
While validation ensures the product meets user needs, verification confirms that the product
is built correctly according to the specifications.
• Focus on Functionality:
System testing focuses on verifying the functionality of the medical device as a whole,
including its features, interfaces, and interactions.
Risk Mitigation:
• Given the sensitive nature of medical devices, system testing plays a crucial role in
identifying and mitigating potential risks associated with software errors or hardware
failures.
Types of System Testing
• Functional Testing:
• Verifies that the device performs its intended functions accurately and reliably.
• Performance Testing:
• Assesses the device's speed, scalability, stability, and reliability under various conditions and
loads.
• Safety Testing:
• Focuses on ensuring the device reacts appropriately to error conditions and prevents harm to
patients.
• Usability Testing:
• Evaluates how easy and efficient it is for healthcare professionals to use the device,
considering aspects like patient safety, human factors, and ease of use.
• Security Testing:
• Checks the device's security measures to prevent unauthorized access or data breaches.
• Recovery Testing:
• Evaluates the device's ability to recover from errors or failures.
• Scalability Testing:
• Determines how well the device can handle increased workload or data volume.
• Reliability Testing:
• Assesses the device's ability to function consistently and predictably over time.
Why is System Testing Important for Medical Devices?
 Patient Safety:
System testing is crucial for ensuring the safety and effectiveness of medical devices, as
errors can have serious consequences for patients.
 Device Functionality:
It verifies that the device performs its intended functions accurately and reliably, ensuring
that it delivers the expected outcomes.
 Regulatory Compliance:
Many regulatory bodies require thorough testing, including system testing, to ensure the
safety and efficacy of medical devices before they can be marketed.
 Cost Reduction:
Identifying and addressing issues early in the development process through system testing
can help reduce costs associated with later fixes or recalls.
Example:
 For an MRI machine, system testing would involve examining all software components to
verify that they all function correctly, enabling accurate imaging and ensuring patient
safety.
 For a pacemaker, system testing would ensure that the software operates effectively
under various patient conditions and responds correctly in emergency scenarios.
13.8.5 Hardware Testing
Hardware testing includes various types of tests depending on the intended use of the device.
Testing that occurs during almost every product development cycle includes the following:
• Vendor evaluation
• Component variation
• Environmental testing
• Safety evaluation
• Shipping tests
• Standards evaluation
• Product use/misuse
• Reliability demonstration
Often, hardware testing, especially that associated with the calculation of reliability
parameters, is performed twice during the development process. The first occurs
immediately after the design phase and evaluates the robustness and reliability of the
design. The second occurs after production of customer units begins. This testing evaluates
the robustness and reliability of the manufacturing process.
13.8.6 Software Testing
Software testing consists of several levels of evaluation. Initially, module testing occurs,
where the individual modules of the software program are evaluated and stress-
tested. This testing consists of verifying the design and implementation of the
specification at the smallest component of the program. Testing involves running each
module independently to assure it works and then inserting errors, possibly through
the use of an emulator. The test is basically an interface between the programmer and
the software environment.
Integration testing occurs after each of the modules has been successfully tested. The
various modules are then integrated with each other and tested to assure they work
together.
System testing consists of merging the software with the hardware to assure that both
will work as a system. Testing involves verifying the external software interfaces;
assuring that the system requirements are met; and assuring that the system, as a
whole, is operational.
Acceptance testing is the final review of all the requirements specified for the system
and assuring that both hardware and software address them.
Software Test Plan
For software validation, a test plan is written prior to executing a test pass. The test plan format follow the format defined in ANSI/IEEE Std
1012-1986. The key aspect to the plan is the description of the software change, and the tests that will be run to prove those software changes are
implemented correctly. The test plan is written anytime a full validation or a regression test is run.
Test Configuration Form
Since it is very important to be able to repeat a test, it is therefore necessary to document the configuration of the equipment used to run a test
against. This documentation is written on to a Test Configuration Form. The contents of one of these forms can vary. However, the primary fields
are date, item, item serial number, and a place for the test engineer to sign their name. The Test Configuration Form becomes part of the test
documentation suite.
Executing Manual Protocol
Executing manual protocol for a formal test involves printing out the test procedures and going through the steps in the procedures. Because these
printouts are a part of the official documentation, the test engineer must sign and date the documents. If the tester finds problems during the test,
he/she will document the issue on the test procedures.
Executing Automated Protocol
Typically, executing automated protocol amounts to setting up a batch job to submit a series of tests to be run. A test engineer fills out a test
configuration form to have a piece of paper to start off the test. The batch job is then run overnight and the results are analyzed the following
day.
Software Validation Test Report
The key items in this report is a summary of what was tested, how it was tested, any problems that were encountered, and a recommendation for
release.
Requirements to Test Cross Reference
This document covers how the requirements were allocated to tests.
Procedures Response Document
As mentioned earlier, all hand written marks on the manual test procedures must be reviewed and provided a closure. The results of this closure
are documented in the Procedures Response document. Typically, each mark up in a test procedure is a software problem, a procedure error, a
procedure deviation, or a comment.
Hardware Test Plan
A comprehensive hardware test plan for a medical device
should outline the procedures, equipment, and standards
used to ensure the device's safety, reliability, and
functionality, adhering to relevant regulations like IEC
60601-1.
Here's a breakdown of key elements of Hardware test plans.

1.Purpose and Scope:

• Define the device's intended use and target users.
• Identify the specific hardware components and functionalities to be tested.
• Specify the regulatory standards (e.g., IEC 60601-1) that the device must comply with.
2. Test Environment and Equipment:
 Detail the necessary testing equipment, software, and fixtures.
 Describe the setup and configuration of the test environment.
 Outline any specific safety protocols or precautions required during testing.
3. Test Cases and Procedures:
 Develop a comprehensive list of test cases based on requirements and potential failure modes.
 For each test case, specify the input conditions, expected output, and acceptance criteria.
 Document detailed procedures for conducting each test, including step-by-step instructions.
 Include test case summaries, descriptions of goals, starting conditions, and equipment relied upon.
4. Test Execution and Reporting:
 Establish a clear process for executing the test plan, including assigning roles and responsibilities.
 Document all test results, including any deviations from expected outcomes.
 Develop a format for reporting test results, including pass/fail status, data analysis, and
conclusions.
 Outline how discrepancies will be addressed and what corrective actions will be taken.
5. Key Considerations for Medical Devices:
 Safety:
Prioritize testing to ensure the device's safety for patients and users, including electrical,
mechanical, and chemical hazards.
 Reliability:
Thoroughly test the device's performance under various conditions to ensure long-term
reliability.
 Performance:
•Verify that the device meets its intended performance specifications, including accuracy,
speed, and resolution.
Questions
1.Briefly explain the Design and development plan of medical device.
2.Explain design verification and design validation of medical devices.
3.Mention the differences between design verification and design validation.
4.Explain the process of design transfer.
5.Explain hardware and software testing.
6.Explain the three verification elements required to carry out verification of design process.
(ref slide-16- 6.7.1)
7.Describe validation life cycle model explaining the procedures followed in different phases
of product development.
8.What is system testing? Explain various types and give definition with example.
9.What are the different methods of design verification?
10.Make design verification and validation plan for a digital thermometer.