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Iec62304 3

This document provides information about a software validation training course that covers the requirements of EN 62304:2006 for medical device software. The course will discuss software life cycle processes, risk management, development, design, verification and validation. It is aimed at those in the healthcare industry involved in developing or supporting regulatory compliance of medical device software. The two day course will include lectures, group exercises and case studies to help participants understand how to apply EN 62304 and fulfill regulatory requirements.

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Abdul Rahman
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247 views

Iec62304 3

This document provides information about a software validation training course that covers the requirements of EN 62304:2006 for medical device software. The course will discuss software life cycle processes, risk management, development, design, verification and validation. It is aimed at those in the healthcare industry involved in developing or supporting regulatory compliance of medical device software. The two day course will include lectures, group exercises and case studies to help participants understand how to apply EN 62304 and fulfill regulatory requirements.

Uploaded by

Abdul Rahman
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Title Software Validation – Introduction to EN 62304:2006

Description The resent amendments to the EU Directives: Medical Devices (93/42/EEC), Active
Implantable Medical Devices (90/385/EEC) and Biocidal products (98/8/EC) as
expressed in the Directive 2007/47/EC concerning software requires the
manufacturer to incorporate software life-cycle processes into his quality system.

The standard EN (IEC) 62304 Medical device software – software life-cycle


processes is a tool to fulfill these requirements.

The IEC 62304 was harmonized in the European Union on 28th November 2008. A
claim of compliance with EN/IEC 62304 now provides a presumption of conformity
with the above mentioned Directives for software

The standard provides a framework of life-cycle processes with activities and tasks
necessary for the safe design and maintenance of medical device software. This
standard provides requirements for each life-cycle process.

This course is held in English.

Course Start Date


2015-06-02 09:00

Course End Date


2015-06-03 17:00

Course Location
In Copenhagen.

Registration and coffee: 08:45 am to 09:00 am.

Course Summary The course details the software validation requirements that need to be addressed
during design control [§7.3 of the EN ISO 13485] for software projects.

There will be sessions on software risk management, development life-cycle,


architecture, design, software verification and validation.

Software validation of proprietary medical device products, subcontracted and off-


the-shelf software will also be covered.

Incorporation of EN ISO 14971, Medical devices – Risk management – Application


of risk management to medical devices and AAMI /TIR 32 Medical device software
risk management into the software life-cycle processes will be shown including
references to the guideline IEC/TR 80002-1:2009 “Medical device software –
Guideline on the application of ISO 14971 to medical device software”

All current documentation of the EU software regulatory requirements will be


included in the course binder.

The format will include lectures, discussions groups and case studies.

Furthermore, this course is designed to give the delegates an understanding of the


EN 62304 standard as a tool to fulfill the regulatory requirements defined in the
extended requirements of the Essential Requirements of the amended Medical
devices Directive (93/42/EEC).

NOTE: The manual for this course is handed out on a CD-ROM / USB Memory Stick
containing PDF files of the course materials when the course begins.

This means that you should bring your laptop/PC to the course if you want to take
notes on the slides during the course.

All guidelines, examples of training, standards etc. used are also stored as PDF files
on the CD-ROM / USB Memory Stick handed out.

Course Target Group The course is particularly suitable for those in the health care products industry,
who are actively engaged in developing or supporting regulatory compliance of
medical device programmable systems.

Some knowledge of medical device regulatory management systems is assumed.


However, there will be a brief introduction to ensure that everyone is "up to
speed". It is recommended that those attending the course either:

• are or will be involved at some level in the implementation medical device


software in compliance to EU Regulations and/or

• have some experience of Programmable Systems, software development and


conformity assessment to the Essential Requirements of the Medical Device
Directive (93/42/EEC) or other requirements.

Course Teachers
Poul Schmidt-Andersen

Price
DKK 10,000 excl. VAT

Included In Price The price includes lunch and refreshments as well as material but not the DS/EN
62304:2006. You can buy DS/EN 62304:2006 for 768 DKK excl. VAT.

Excluding accommodation.

By simultaneous registration of 3 or more people you will get a 10% discount.

Course Program Day 1

09:00 - 09:30 Introduction

• Welcome by DGM Presafe


• Presentation of the tutor
• Presentation of the delegates
• About the course/learning objectives

09:30 - 10:15 Regulatory requirements to Medical Software


• Introduction to EU software regulation
- Updated Medical Devices Directive
- Harmonized standards
10:15 - 11:15 Prerequisite to Software Validation
• Quality Management System
• Integrated Risk Management System
• Assessment procedure for software safety classification

Software Life Cycle Processes


• Definitions
• Overview

Background and Structure of


• EN / IEC 62304 Medical device software – software life-cycle processes and
• AAMI TIR32 Medical device software risk management
• IEC/TIR 80002-1:2009 Medical device software – Guideline on the application of
ISO 14971 to medical device software”

11:15 - 12:00 Software Development Planning


• Developing life-cycle plan
• Verification and validation plan
• Plan for testing
• Risk management plan
• Configuration management and documentation
• Use of tools

11:45 - 12:00 Software development planning training example

12:00 - 12:30 Software Requirement Analysis


• User requirement specifications, translated to
• System requirement specifications, translated to
• Software requirements
• Verification of Software Requirements.

12:30 - 13.15 Lunch

13:15 - 14.00 Group exercise I (Requirements) and report back

14.00 - 14:30 Software Architectural Design


• Transform software requirement into an architecture
• Identify software items & units
• Identify SOUP (Software Of Unknown Provenance) blocks
• Segregation of software elements for risk control

14:30 - 15:15 Software Detailed Design


• Refine software architectural design into SW items and units
• Verify detailed design

15:15 - 15:30 Refreshments

15:30 - 16:00 Software Unit Implementation and verification


• Software unit verification strategies
• Software unit verification
• Software unit test coverage
16:00 - 17:00 Group exercise II (Detailed design) and report back

Day 2

09:00 - 10:00 Software Integration and Integration Testing


• Verification of integration of units into items into software systems according to
plan
• Integration test procedures
• Integration testing plan and test records
• Regression testing
• Problem resolution

Software System Testing


• Test plan for all software requirements
• Verification of software system test plan
• System test records
• Problem resolution/retest after changes

10:00 - 10:30 Software Release


• Test plan for all software requirements
• Verification of software system test plan
• System test records
• Problem resolution/retest after changes

10:30 - 12:30 Software Risk Management Process


• Analysis of software contributing to hazardous situations
• Risk control measures

12:30 - 13:15 Lunch

13:15 - 15:30 Group exercise III (Risk assessment) and report back

15:30 - 16:15 Software Maintenance process


• Software maintenance plan
• Problem and modification analysis/resolution process
◦Establish customer problem feedback process
◦Problem report (problem classification)
◦Analyzes/investigate problem
◦Software CAPA
◦Verify solution Change requests
• Modification implementation
◦Establish process to implement modifications/changes
◦Re-release of software.

16:15 - 16:45 Software Configuration Management process


• Configuration identification (Units, Items and SOUPs)
• System configuration documentation
• Change control

16:45 - 17:00 Questions

17:00 Close
We reserve the right to make changes in the program.

Area of Interest Medical Devices

Area Of Business
Certification

Contact Person
Sales & Business Support, Presafe Denmark A/S
Søren Juul Regnersgaard
Tlf.: 3945 4986

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