Dr. Bassil Akra

CEO AKRA TEAM GmbH

[Dr. Bassil Akra @dr_akra]

@mrtweetusa 67854

[Dr. Bassil Akra @dr_akra]

@mrtweetusa 56

[Dr. Bassil Akra @dr_akra]

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…https://t.co/WCS1HZAm2P

[Dr. Bassil Akra @dr_akra]

#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 😅🤪? https://t.co/Ry4qjhj7VJ

[Dr. Bassil Akra @dr_akra]

Check the new #NANDO Website Structure: https://t.co/2qA0lGBfVp

[Dr. Bassil Akra @dr_akra]

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…https://t.co/LNEIp9yaC5

[Dr. Bassil Akra @dr_akra]

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 😉 https://t.co/z51yLsJVEm

[Dr. Bassil Akra @dr_akra]

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…https://t.co/iz6j87T666

[Dr. Bassil Akra @dr_akra]

Medical background and Statistical Competence are essential in planning, conducting and reporting of successful #Clinical investigation. Very helpful presentation by Shelley Jambresic at #MedTechSummit2023 https://t.co/fusrSTrW1t

[Dr. Bassil Akra @dr_akra]

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 https://t.co/JCaVRKTBDq

[Dr. Bassil Akra @dr_akra]

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…https://t.co/2IPYfaaxBc

[Dr. Bassil Akra @dr_akra]

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…https://t.co/f5RyFy9vl4

[Dr. Bassil Akra @dr_akra]

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…https://t.co/aIkuBSQJyk

[Dr. Bassil Akra @dr_akra]

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…https://t.co/FGFjTZi6QS

[Dr. Bassil Akra @dr_akra]

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…https://t.co/mYAqgQBsiu

[Dr. Bassil Akra @dr_akra]

#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 https://t.co/oyqZDYBJVl

[Dr. Bassil Akra @dr_akra]

Don´t miss this event, join us and learn more about the current interpretation in the EU!

https://t.co/blbDzarnec

#Heartvalve #CEMark #Notifiedbody #ISO https://t.co/3CfkpJs2qC

[Dr. Bassil Akra @dr_akra]

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 😅 https://t.co/A4EaL2AXHF

[Dr. Bassil Akra @dr_akra]

Don’t miss this event, we are looking forward to seeing you all online!!! https://t.co/vC3vqjKfmh

[Dr. Bassil Akra @dr_akra]

Be there and join our discussion! https://t.co/ZlSAvgH2Xk