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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 lnkd.in/e3nBU3qP

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…lnkd.in/ewjDAMpu

Be there and join our discussion! lnkd.in/e9CBCD_r

Don’t miss this event, we are looking forward to seeing you all online!!! lnkd.in/eXyxDUKd

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 😅 lnkd.in/efei9dwY

Don´t miss this event, join us and learn more about the current interpretation in the EU! lnkd.in/esREVt3p #Heartvalve #CEMark #Notifiedbody #ISO lnkd.in/e3acRNyE

#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 lnkd.in/eJ3a-bMb

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…lnkd.in/eRZKPMAd

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…lnkd.in/emjbfZJh

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…lnkd.in/eVChDG_Z

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…lnkd.in/ed-tPcug

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…lnkd.in/eKrz7DWS

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 lnkd.in/eDX4wz-y

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

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…lnkd.in/eCJ9iMqc

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 😉 lnkd.in/euFFZE4y

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…lnkd.in/ezwt_5Tg

Check the new #NANDO Website Structure: lnkd.in/eGPSJiVq

#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 😅🤪? lnkd.in/ePBJQRQX

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…lnkd.in/ekafNmpz