MICHAEL SCHAEFER
Quality Management and Regulatory Affairs in Medical Devices
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So what is the difference?
Quality-on-site.com is a platform for quality practitioners provided by Michael Schaefer, Expert for Quality Management and Regulatory Affairs in Medical Devices. It is my goal to provide and exchange valuable information and knowledge needed for continuously improving quality methods in medical device industries to reduce patient risk, increase quality and fulfil regulatory requirements. Training and support is available upon request.
For more information and networking contact info@quality-on-site.com
The information on this site provided is free; however the author does not take any responsibility for contents and correctness.
My skill set
A quality system on its own will not improve product or process quality. Applying suitable tools and methods are crucial to ensuring long-term success and customer satisfaction. Over the past years I was privileged to develop further my own skillset to implement both compliant and cost-efficient quality systems by focusing on patient safety and error prevention. Take a look into my skill set!
The latest (LinkedIn) Gossip
Benefit-Risk under MDR 2017/745
Nach einer intensiven Vorbereitung freue ich mich sehr mit der TÜV SÜD Akademie ein neues Seminar starten zu können. Unser Seminar hebt die Nutzen-Risiko-Analyse als Herzstück der Konformitätsbewertung unter der MDR 2017/745 hervor. Obwohl diese Analyse nun als unverzichtbar gilt, fehlen hä
ufig konkrete Vorgaben für Umsetzung und Dokumentation. In unserem eintägigen Lehrgang lernen Sie nicht nur die Grundlagen der Nutzen-Risiko-Analyse kennen, sondern auch die verschiedenen Aufgaben und Zusammenhänge des Risikomanagements gemäß ISO 14971 in Verbindung mit der klinischen Bewertung. Wir sind sehr gespannt, ob wir Ihnen eines der schwierigsten Themen der MDR praxisnah vermitteln und somit etwas Licht ins Dunkel bringen können.
Audit hint: impact assessment of changes
Audit hint: Please make sure that you document a proper impact assessment of changes. Especially for design changes you must evaluate, for example, impact to shelf-life, bicompatibility, and sterilization. If you are not able to provide such assessments during the audit it might remain unclear, if the modified product will remain as safe as the previous version. The impact assessment must also conclude if regulatory activities are required.
MDCG 2023-3 Rev 2
The MDCG Guidance for Vigilance was revised again. Practically, there are no relevant changes for manufacturers. Please note that you „must allow 48 hours (equivalent to two weekdays) for receipt of comment on the draft FSN, unless the nature of the FSCA dictates a shorter timescale e.g. in the case of a serious public health threat“ (Question 20 footnote 34).
Revalidation of software
Audit hint: Validation of software used within the quality management system as per ISO 13485 is not new and most of the companies did their homework. However, keep in mind that any change to such software must be assessed if revalidation is required. Just recently I audited a software which was validated two years ago and a major release was conducted in the meanwhile without any documentation.
Medical device recalls in Canada
Changes to Canadian medical device regulation with respect to recalls: get your procedures ready for Dec 17, 2024. Make sure that the revised requirements are implemented. HC offers a nice flowchart guiding along the recall procedure. For voluntary recalls, your communication to HC will start 24h after making the decision to recall, on the day on the recall and 30 days after completion. Type III recalls will not need to be reported.
Audit hint
Clause 7.3.10 of ISO 13485:2016 requires manufacturer „to maintain a design and development file for each medical device type or medical device family“. During audits I often come across missing design development files. This was often caused by non-compliant quality systems in the past paired with a lack of regulatory oversight. Actually it is no rocket science to retrospectively generate design development files. This can often be accomplished within a few days. Let me know if you need support.
Design Validation
Do you know the following sentence? „Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded“. For sure you do, or? It’s from clause 7.3.7 in ISO 13485:2016. If you are involved in engineering of medical devices, please be reminded to adhere to this requirement. By the way, it applies as well to PQ in the area of process validation. In each of my last three audits I came across one violation in those areas: Non-equivalent design validation lots, PQ having been done with early prototypes or even commerical products not being representative.
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