Michael Schaefer’s Post

FDA QMSR, ISO 13485 and Risk Management as per ISO 14971 Are you looking for a free, well-written and easy-to-understand guidance how to integrate Risk Management into your FDA QSR compliant QMS in order to fulfill ISO 13485 requirements? Prior to visiting any expensive seminars or even hiring external consultants like me, you may just read the MDSAP audit approach which is available for free as pdf on the FDA website😎! The MDSAP Audit approach is clearly showing in italic blue font all the ISO 13485:2016 requirements where Risk Management is needed. As an authorized MDSAP auditor I can fully recommend this document as it delivers a full overview of all topics where the integration of risk management will be challenged during audits and inspections. You will notice, that your good common sense may already suffice to transition safely from QSR to QMSR until 2026. In general, the MDSAP audit document guides you the path to a fully compliant QMS as per ISO 13485 and international regulations. For sure we will see updates to the document as we approach transition deadline. Usually, it is updated annually around this time of the year!

Recently I conducted an internal audit in a small company. Like many, the company was struggling to cope with the costs associated with being a legal manufacturer of medical devices. During the audit we detected several areas, where QMS simplification could help reducing daily workload. One example was the area of quality policy, objectives and KPI. For that purpose I am attaching a document showing a simple but still compliant approach. Please don’t overdue this portion of your QMS.

Manuel Grandy thanks for sharing this information

Are you struggling to get Process Validations done? Process validation (as per chapter 7.5.6 of ISO 13485:2016) is not a new requirement and should be readily in place since decades. Unfortunately, industry took the chance to navigate safely through audits and inspections although not having accomplished this task. The new European MDR is now finally closing the escape routes and manufacturers are suddenly struggling to get the stuff done. For me IQ, OQ and PQ was actually my first task when I started 2001 in medical devices and since then I never stopped doing validations. Now, 20+ years later I provided hundreds of training to industry, notified body and authorities and still I love doing validations. If you need support in doing process validations (including statistical sampling plans) I would be more than happy supporting you. Just let me know! Please note that there might be several product codes where I will be NOT available (e.g. MDN 1201, 1202, 1203, 1208, 1214).

The final rule to the US QMSR (revising 21CFR820 by referencing ISO 13485:2016) provide a lot of insight into FDA's current thinking. For example, the following statements are interesting: "Nonconforming product discovered before or after distribution should be investigated to the degree commensurate with the significance and risk of the nonconformity, consistent with Clause 8.3 of ISO 13485 and its subclauses. At times an in-depth investigation will be necessary, while at other times a simple investigation, followed by trend analysis or other appropriate tools will be acceptable. Consistent with Clauses 8.2.5 and 8.2.6 of ISO 13485, among other things, the requirement for measurement and monitoring applies to process and quality system nonconformities, as well as product nonconformities. For example, if a molding process with its known capabilities has a normal 5 percent rejection rate and that rate rises to 10 percent, an investigation into the nonconformance of the process must be performed." I strongly recommend reading the final rule!

Statistical sampling plans for medical devices The picture gives a generic overview on published sampling plans for medical devices. Some of the plans mention AQL, some RQL and some just numbers. Therefore I arranged all plans as per C/P-levels. Do you know further plans that should be added? If yes leave a comment....

Haben Sie Fragen zur Berichterstattung von Reklamationen, FSCA/FSN? Dann sollten wir uns am 28.02.2024 online treffen! Wir freuen uns, Ihnen die wesentlichen Grundlagen in unserem neuen Training vermitteln zu dürfen. Sind Sie dabei? https://lnkd.in/ezEdJR7y