Marta Aznar Ibáñez

- What to Include in Your PCCP: A Complete Guide. For full episode check: https://lnkd.in/g5YwiKW9 Monir El Azzouzi María Diez Zaera #easymedicaldevice #medicaldevice #regulatorycompliance

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We need clarity on how the term “structured dialogue” will be defined. The MDCG’s current guidance leaves room for interpretation, which is problematic for all companies, especially SMEs. We need to understand if this process will be similar to the QSub/Consultation Process used by the FDA/PMDA, where companies can submit documents and receive constructive feedback before starting testing or clinical trials. Or will the Notified Body (NB) consider this as consultancy and not provide feedback? Will structured dialogue allow companies to engage early, have their clinical protocol reviewed, and receive a determination on its adequacy at that time? The same question applies to the testing roadmap—will companies receive feedback to ensure they meet NB requirements, similar to the FDA’s process? Will NB's have published timescales for responses (e.g., the FDA’s 70-75 days)? Currently, response times are slow, and companies often have to chase for acknowledgment of their submissions. Having clear, structured dialogue processes and timelines would greatly benefit companies in navigating regulatory requirements efficiently

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Stability, shelf-life or journey hazard simulation? I stick to stability testing as it aligns with terminology in ISO 11607 and is defined as the following: Stability testing demonstrates that the sterile barrier system maintains integrity over time. Performance testing on the other hand evaluates the interaction between the packaging system and products in response to stresses imposed by the manufacturing, sterilisation and handling environment. A key difference between these two. Monir El Azzouzi Easy Medical Device #MDR #RegulatoryAffairs #TechnicalDocumentation #StabilityTesting #Sterilisation

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🌟 Elevating Medical Device Quality Systems: Key Insights from FDA Observations 🌟 From retrieving five years’ worth of medical device FDA observations, patterns emerged. The ten elements of a medical device quality system referenced most (keyword search) in the last five years of FDA observations worldwide are: 💻 CAPA: Corrective and Preventive Action (CAPA) processes are critical for identifying and addressing non-conformities. Effective CAPA ensures that underlying issues are not only corrected but also prevented from recurring, maintaining the integrity of the quality system. 🔬 Product Safety: Ensuring product safety is paramount. This involves rigorous risk management practices, continuous monitoring, and adherence to safety standards to protect patients and end-users from potential hazards associated with medical devices. 📓 Process Validation: Rigorous validation processes are the cornerstone of ensuring that every step in medical device manufacturing is validated to meet quality standards. 📒 Procedures: Well-defined and documented procedures lay the foundation for consistent processes, ensuring adherence to regulatory requirements and product quality. 🔍 Investigations: Thorough investigations into deviations or discrepancies are crucial for identifying root causes and implementing corrective actions to prevent recurrence. 🖋 Data Integrity: Upholding data integrity principles ensures the accuracy, completeness, and reliability of data throughout the product lifecycle. 📐 Design Controls: Robust design controls ensure that medical devices meet user needs and intended uses. This involves meticulous planning, design verification and validation, and documentation throughout the product development process. 🌍 Environmental Monitoring: Monitoring and controlling environmental conditions within manufacturing facilities are essential to prevent contamination and maintain product integrity. 📏 Calibration: Regular calibration of equipment is necessary to ensure that instruments and devices are performing accurately and consistently, thereby ensuring the reliability of test results and measurements. 🏫 Training: Continuous training programs for staff are vital to maintaining a high level of competence and awareness of regulatory requirements, quality standards, and best practices within the medical device industry. Over the next weeks, we will be sharing deeper insight into these top 10 FDA observation elements. 📧 Comment or like if you would like to discuss further. #qualitysystem #FDA #meddevice #continuousimprovement

Have your say… Annexes to “amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council”

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In our experience, one of the most feared requirements of the EU MDR is the dreaded determination of clinical benefits and many manufacturers hope that if they either ignore them or claim that there are none, the problem will disappear. Unfortunately, like the proverbial elephant in the room, the requirement will not go away, and if your regulatory consultant is not making this clear before submission, your Notified Body will. If a device meets the definition of a medical device, it already implies a clinical benefit – whether direct or indirect. For example, if a medical device provides “diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease” (Article 2(1) MDR) – those are all potential clinical benefits.  But what do you do once you've identified these benefits? Now you must make sure they are meaningful and measurable. Direct clinical benefits are usually easier to evidence such as reduction in pain (pain VAS scores) or improvement in respiratory symptoms (BORG score). However, indirect benefits might require a more creative approach to link certain metrics/outcome parameters and the benefit experienced by the patient. Either way, avoidance of the clinical benefit “elephant” will not result in a successful EU MDR submission so rather tackle it head on, and if you need support, we're here to assist. Visit our website to learn more 👇 https://lnkd.in/dSXC_in #ClinicalBenefits #EUMDR #MedicalDevice #MantraSystems

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#medicaldevices must not only be #safe but also demonstrate #clinicalbenefits and an acceptable benefit-risk ratio as stipulated in Annex 1 of the #MedicalDeviceRegulation (MDR), which requires a specific document known as a Clinical Evaluation (https://lnkd.in/dqnqGMEq). The #MDR intersects notably with the #GDPR. Article 61, paragraph 1 of the MDR, which covers #ClinicalEvaluation, mandates that device conformity with the #safety and performance requirements set out in Annex I must be substantiated by #clinicaldata providing sufficient evidence, including applicable data as referenced in Annex III. This raises questions about what constitutes ‘clinical data’ under the MDR, which may include a variety of #personalhealthdata but is not wholly synonymous with ‘#personaldata’ as defined under the GDPR. Article 2, paragraph 48 of the MDR specifies that clinical data may come from #clinicalinvestigations of the device, relevant scientific literature, or #postmarketsurveillance, among other sources (https://lnkd.in/dn6RDh2m). A separate analysis is warranted for ‘clinical investigations’ and ‘clinically relevant information’ (https://lnkd.in/d8vYJfYe). Clinical investigations are defined by the MDR as systematic studies involving human subjects to assess a device's safety or performance. The regulatory details for such investigations can be found in Articles 62 to 81 and Annex XV of the MDR. Like pharmaceutical trials, the legal basis for #dataprocessing in these cases often leans towards #consent under GDPR, though this approach has faced criticism regarding its suitability. Clinically relevant information also includes data from post-market surveillance and the Post-Marketing Clinical Follow-Up (#pmcf), which involves continuous updating of clinical evaluations and proactive #datacollection on devices already in use (https://lnkd.in/dhckJEAG). This involves new processes within companies that must be analysed and structured to ensure proper handling of personal data, adhering to #privacybydesign and #PrivacybyDefault principles outlined in Article 25 of the GDPR. Medical device manufacturers, don't hide and seek with the GDPR. It always knows where you are!

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🔔 EU MDR/IVDR News - CAPA plan assessment The Medical Device Coordination Group (MDCG) has published "MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams" This guidance document is intended for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Source of the document - https://lnkd.in/d8EytXtM All MDCG documents can be found here: https://lnkd.in/eQJ7zvz9 #intelligence #notifiedbody #notifiedbodies #audit #ivd #euivdr #eumdr #medicaldevice #medicaldevices #surveillance #regulatoryintelligence #clinicalinvestigations #capa

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Follow us on Instagram! Due to technical issues, CAPA had to start a new page and many of our followers haven't found us yet. If you think you already follow CAPA, hop on over to Instagram and make sure! If you don't follow us, you totally should! Go find @CAPA.ATX so you can stay up to date on all the fun around here! #instagram #capa #followus #paralegals

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#medicaldevices #iso14971 #riskmanagement 📄"At its core, ISO 14971:2019 outlines a risk management framework that supports manufacturers in identifying, evaluating, and mitigating risks associated with medical devices, including software as a medical device (SaMD)", writes Noa Mizrachi. Following an excellent week in Phoenix for the Health-ISAC Americas US Summit, Noa provides a primer on the standard that's shaping risk management in the medical devices sector.🥼 🔗 Read Noa's full commentary on our blog: https://lnkd.in/dTdANJ_k #productsecurity #cybersecurity #sbom #contextdriven

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New harmonized standard under EU MDR: EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) #mdr #medicaldevices #regulatoryglobe

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MDRChats by ChatMDR is back: Conformity Assessment Route under the MDR! In this episode, we dive into the key differences in conformity pathways for medical devices. #MDRChats #ChatMDR #MedicalDeviceRegulation #ConformityAssessment #RegulatoryAffairs #Compliance

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Top Management Doesn’t Care About Regulatory—Should You Run? Being a regulatory affairs or quality management expert can be one of the toughest roles in a company. Why? Because there are daily struggles: → The department costs money but doesn’t generate revenue. → They often enforce rules and “police” other departments. → They continuously communicate new tasks for audits and legislation. But what happens when top management doesn’t care about regulatory? If leaders dismiss regulatory as nonsense or only as a hurdle to market entry, things get worse. When management doesn’t focus on the regulatory backlog or recurring activities like audits, it raises serious red flags. Should you quit and move on? Or can this be addressed? Here are 5 strategies to get top management on board: 1. Regulatory and Quality Are Market Entry Tickets → Regulatory doesn’t generate revenue directly, but without certifications, revenue is zero. → Compliance is the starting point for market access and revenue generation. → Frame regulatory as a business enabler, not just a cost center. 2. Without Management Support, No One Else Will Care → Leadership defines company culture. If they don’t prioritize regulatory, no one will. → Strong support creates allies within other departments, boosting cross-functional cooperation. → Managers need to lead by example to foster a regulatory culture. 3. It’s All About Patient Safety → Medical devices carry inherent risks, much higher than most other product types. → Regulatory ensures safety, and safety builds trust in the industry. → Remind them: What if they were treated with a low-quality device in a hospital? 4. High Quality Drives Revenue → Bad quality destroys trust—ever boycotted a brand for poor products? → Medical devices are no different. Buyers choose based on quality and reputation. → Superior quality leads to better customer retention and word of mouth. 5. Regulatory Budgets Are Investments, Not Expenses → RAQA teams don’t enjoy endless paperwork or inefficiency. → With the right tools and budget, compliance processes can be streamlined. → Investing in regulatory speeds up certification and boosts overall quality. But what if these arguments don’t work? If management remains uninterested, it might be time to reconsider. A company that tolerates, rather than embraces, regulatory compliance can create long-term frustrations. P.S. What additional arguments would you use to convince top management? Let’s share ideas! ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I’m Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let’s connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

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[LIVE WEBINAR] 📆 May 13, 9 am ET / 3 pm CEST. The EU MDR requires that the level of clinical evidence is justified and specified by the manufacturer during the clinical evaluation process. But the MDR does not define what is considered sufficient. It is incumbent on you as the manufacturer to determine what sufficient clinical evidence means for your device, based on its stated indication for use. Join this live webinar where Dr. Peter Bowness, VP Regulatory Affairs & Operations at @MCRA, will discuss the background, definitions, guidance and practical application of the determination of clinical sufficiency to enable manufacturers to understand this critical and complex requirement. Save your seat: https://bit.ly/3wpQhMK.

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Response to Survey on CAPA FDA 483 Citations: Reflections and Recommendations A few weeks ago, I asked why CAPA remains one of the top areas of FDA observations noted on 483s. Nearly 70% of participants highlighted "lack of technical rigor" and "speed of KPIs vs quality of work." Here are some general recommendations (not all-inclusive) on actions to consider for improving or setting up a CAPA system to achieve better outcomes. Technical Rigor Having an established procedure for conducting Corrective and Preventive Actions (CAPA) is essential. There are many tools available for conducting investigations. One highly recommended methodology is DMAIC (Define, Measure, Analyze, Improve, and Control). DMAIC is a methodical, data-centric approach to problem-solving that aims to identify and rectify inefficiencies within a process, thereby enhancing outcomes and ensuring improvements are consistent and predictable. Typically, industries use DMAIC to drive process excellence, reduce variation, and lower costs. DMAIC is also crucial for training and certifying Green Belts and Black Belts in many firms. Companies with an established Process Excellence group should leverage this expertise to embed these practices into the CAPA system. CAPA KPIs vs Quality of Work Historically, firms have established lagging CAPA metrics, such as CAPA aging and CAPA effectiveness, which are part of their Quality Plans and Management Reviews but are not reviewed routinely. Some firms conduct Management Reviews quarterly, bi-annually, or annually. To improve the use of KPIs, firms must treat CAPAs like projects. For example, every CAPA phase (investigation, action plan, effectiveness, phase extensions) should have a defined number of deliverables. Firms need to review how well these deliverables are executed and if they are on time. One way to do this is to measure the % Attainment of Deliverables on time, which is a leading indicator for the CAPA phase. Resource Management Another significant constraint at many firms is the lack of focus on resources to work on CAPA. Resource management and allocation is always a balancing act. There is no perfect setup for a CAPA system and structure. However, here is a short list of roles that can help improve the quality of work. Improving technical rigor, as mentioned earlier, should enhance the quality of work. CAPA Administrator: Monitors the portfolio of all CAPAs, manages the CAPA board, and handles escalations. CAPA Specialists: Assess CAPA compliance with procedures and content. Independent Reviewer: Evaluates CAPA compliance and technical rigor, working with CAPA owners to resolve issues. CAPA Investigators: A dedicated team that works on critical steps of the CAPA, such as validating the problem statement, scope, defining initial mitigations/interim controls, and root cause analysis. This team partners with cross-functional teams to define action plans and implementation activities.

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Q: If the lab use aspecimen type not included in the manufacturer's instructions does it needs validation study for the test ? Answer Yes, changing the specimen type is a modification of the test and requires a validation study in compliance with COM.40350. Ref.CAP LAP program COM.40350.

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Differences between US FDA and EU MDR Usability studies requirements Understand the divergent demands of FDA and EU MDR for medical device usability testing. Learn about IEC 62366-1, components of Usability Engineering File, and specific MDR requirements. Read more: https://lnkd.in/gRuXnSxW #FDA #EUMDR #MedicalDevice #UsabilityTesting #HumanFactors #IEC62366 #Healthcare #MedicalRegulations #MedTech #MedicalCompliance #UsabilityEngineering #MedicalSafety #MedicalTechnology #RegulatoryCompliance

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