CEO AKRA TEAM GmbH
Joined September 2016
- Tweets 576
- Following 108
- Followers 204
- Likes 6
1 Photos and videos
7 Jul 2023
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
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5 Jul 2023
#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
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26 Jun 2023
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
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22 Jun 2023
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
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21 Jun 2023
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
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21 Jun 2023
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
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21 Jun 2023
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
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21 Jun 2023
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
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21 Jun 2023
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
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21 Jun 2023
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
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21 Jun 2023
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
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21 Jun 2023
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
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12 Jun 2023
#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
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18 May 2023
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
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18 May 2023
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
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30 Apr 2023
Don’t miss this event, we are looking forward to seeing you all online!!! lnkd.in/eXyxDUKd
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19 Apr 2023
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
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10 Apr 2023
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
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