Two full days of #EUMDR in Brussels. Thank you Bioevents - Sharing Biomed Knowledge for hosting this event to help professionals with basic MDR knowledge going back to the foundation of the regulation. It was a real workshop which was shaped with my help…

#Software #validation is key, not just medical devices but all kind of software must be validated to avoid such 🙈 messaging. Check my personal experience with boarding passes the last weeks. Compare boarding time with gate closure time. No comments 😅🤪?

Generate videos in just a few seconds. Try Grok Imagine, free for a limited time.

Check the new #NANDO Website Structure:

A big thank you for all our customers who value and trust our services. The Team at #AKRATEAM and I will continue do all possible to support devices getting timely to the market ensuring that the healthcare system in the #EU is receiving safe and well-per…

I missed it this time Oliver Bisazza, but I will be there next time. I just received positive feedback about it 👏 Good job as usual 😉

Paul Piscoi shared updates from the CI Group during the MedTech Summit 2023 . Key ongoing activities:. MEDDEV on clinical evaluation is under update.Device specific guidances are under preparation .SSCP Guidance is under update. Manufacturers will upload…

Medical background and Statistical Competence are essential in planning, conducting and reporting of successful #Clinical investigation. Very helpful presentation by Shelley Jambresic at #MedTechSummit2023

Shaloo Sood Kuthiala, PhD from Straumann Group presenting in a simple manner the difference between Hazard, Hazardous Situation and Harm. Check this out!. #RiskManagement #FMEA #MDR

Good real world experience summary by Wojciech Bobela on Post-Market clinical investigation. Full Annex XV Requirements Submission is required in #Poland - This is applicable for PMCFs which are in other member states exempted from NCA Approval. Also, F…

Bianca Lutters presenting on Clinical Investigation Planing to meet EU #MDR. Are sites interested in participation?. Are patient interested to participate?. Is it ethical? . Various questions that must be asked before deciding on the best method to achie…

Very good recommendations from Shweta Agarwal, PhD and Nataliya Deych at the MedTech Summit 2023. Plan systematically.Request a voluntary scientific opinion if your device is falling under the scope of the expert panel .Ask for a structured conversation w…

Esther Valk from #Medtronic and Klaus Schichl from #Biotronik presenting on the Q&A from the #MDCG 2021-6 . Key message: be careful, the Union Market is still not harmonized. Therefore, it is good to make use of presubmission meetings with the responsible…

Nebojsa Serafimovic is sharing the regulator’s perspective during the #MedTech Summit in Brussels. Key information: .1. A new #MEDDEV on clinical evaluation (2.7/1 Rev. 5 or MDCG) is under preparation 🥳.2. In Q4/2024 Switch of national systems to a mand…

#OMTEC 2023 . Looking forward to seeing you all in Chicago. Join us and learn more about the regulatory implications on orthopedic industry. Gregory Jacobson, @LeanRAQASystems, Matthias Fink, Balazs Bozsik and Dan Goldstein

Don´t miss this event, join us and learn more about the current interpretation in the EU!. #Heartvalve #CEMark #Notifiedbody #ISO

It is nice being in #Tokyo again, meeting previous TÜV SÜD - Healthcare & Medical Devices Colleagues and enjoying the good food which is typically presented by my good friend Dr. Andreas Stange (The Food Tester 😉). This post is extra for you my friend 😅

Don’t miss this event, we are looking forward to seeing you all online!!!

Be there and join our discussion!

3rd Annual EU Post-Market #Clinical Evaluation Planning Conference in Paris. Two recommendations:. #PMCF is not a unidirectional method. Review and justify the validity of the method by considering the open questions to be addressed. Regulatory processes…

Don´t miss our annual TEAM-PRRC Event, Register now!. I will be there :) and looking forward to seeing you in Strasbourg!!!. Elem AYNE, Anne Jury, Ronald Boumans and Jean-Louis DIVOUX