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. 

Professional

Predictable

Patient-oriented

Our Services

EU MDR

The Regulation (EU) 2017/745 on Medical Devices.

EU IVDR

The Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices.

Specific Topics

Cross-cutting and global subjects.

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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