Your experts for Regulatory Affairs
We are a highly specialized consultancy supporting various stakeholders to bring medical device, in-vitro diagnostic and combination device products to market in a timely manner and in line with complex legal obligations.
Our Services
Meeting and Training
Explore our options for virtual meetings and trainings and get in contact.
Introductory Meeting
15 min free of charge web conference with Dr. Bassil Akra.
Consultancy Hour
For questions related to QMS, TD, CER/PER or PMS/PMC(P)F.
What our customers say
"AKRA TEAM covers it all! Over the last two years, we have benefitted from clear MDR guidance and wise counsel that has enabled us to navigate clinical expert panels, complicated post-market clinical follow up, derogations, drug dossiers, and everything in between." August 2023
Rita Guzzetta
Vice President, Medtronic Cardiac Rhythm Management
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Customers Worldwide
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Years of Experience
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