Michael Schaefer Quality Management and Regulatory Affairs

Bereits jetzt freue ich mich auf die tolle Weiterbildung für Neueinsteiger und Quereinsteiger! Jetzt anmelden für 2025/2026. https://lnkd.in/eR_VQ9cW

https://lnkd.in/erPVkJcM A lot of interesting input for economic operators of medical devices must be read and understood due to the new DIRECTIVE (EU) 2024/2853 on liability for defective products. For example, the following is interesting for the risk management process: "However, warnings or other information provided with a product cannot be considered sufficient to make an otherwise defective product safe, since defectiveness should be determined by reference to the safety that the public at large is entitled to expect. Therefore, liability under this Directive cannot be avoided simply by listing all conceivable side effects of a product. When determining the defectiveness of a product, reasonably foreseeable use also encompasses misuse that is not unreasonable under the circumstances, such as the foreseeable behaviour of a user of machinery resulting from a lack of concentration or the foreseeable behaviour of certain user groups such as children." The directive also influences, for example, document retention times as it might be possible to initiate proceedings up to 25 years after placing the product on the market (plus 3 years limitation period).

Continuous learning is key to any expert and specialist. Therefore, trainings and seminars, either in person or online, are an essential part of our medical device industry. Based on my background and experience I might be the right person to support your needs. Take a look into my schedule and my offers! https://lnkd.in/d3m8givy

Are you looking for templates for medical device quality systems? You will find some on my new website https://lnkd.in/ecYJTR4C

Die nationale Norm DIN 2304-1 für Klebeprozesse wurde durch die ISO 21368:2022 ersetzt. Wie meist in meinen Trainings zur Prozessvalidierung diskutiere ich die "Klebenorm" als Stand-der-Technik für Klebeprozesse. Auch gestern konnte ich wieder die Neugierde bei einer Teilnehmerin wecken. Dabei hat sie auch gleich festgestellt, dass die nationale Norm nun durch die internationale ersetzt wurde. Also, bitte aktualisiert Eure Normenliste und lest Euch in die wenigen Änderungen ein.

not a great result: "The implementation of PMS was found to be inadequate at all 13 manufacturers visited in 2023 and 2024. There was little to no difference in the number and type of non-compliances between the various categories of medical devices inspected. Manufacturers perceive the PMS requirements from the MDR and IVDR to be complex". https://lnkd.in/eAGAp-A6

https://lnkd.in/eiiytw3 There are two new trainings for the new QMSR available.

MDR Audit hint: MDR 2017/745 article 10.16 requires that manufacturers shall "provide sufficient financial coverage in respect of their potential liability". As an auditor I will have to verify that such coverage is in place. An insurance policy is welcome, however the manufacturer will have to explain why that amount of money would be sufficient. Additionally, please make sure that all countries you are distributing to are covered. I saw some policies where France was excluded.

Did you rescue your 93/42/EEC (MDD) products on stock in the warehouse? Another due date under 2017/745 (MDR) is approaching fast. If you are still placing legacy MDD products on the market under article 120.3 of MDR, a signed contract with a notified body must be in place Sep 26, 2024 to show that the MDR certification process was initiated. All legacy MDD products not covered by such contracts must not be placed on the EU market after that day! So you are better off to have your contract (and confirmation letter from the notified body) or to make sure that all products are out of your warehouse at the due date!

The MDSAP Audit Approach was updated (no huge changes in contents).