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
"CROMA engaged with Bassil Akra and Team for MDR compliance projects. He supported us in understanding the critical steps towards MDR certification and bringing class III combination devices to MDR CE. His experience and knowledge was very supporting both in delivering for practical clinical work packages and templates as well as in strategic communication with the notified body. I appreciate Bassil´s approach in being always accessible, pragmatic and straight forward delivering results. Less general talking more outcome, that is how consultancy should be. Thank you again AKRA TEAM for your support."
November 2023
Arkan Zwick, PhD
Regulatory Affairs Corporate Director, Croma-Pharma GmbH
"AKRA TEAM came to the rescue with a complex and protracted clinical evaluation of high risk medical device softwares. We highly appreciate Bassil’s enormous knowledge of the relevant guidelines and regulations, his personal support in our communication with the Notified Body, and his team’s effort in reviewing CEP, CER, SSCP, and PMCFP, all of which was done in a thorough, precise, and timely manner. MED-EL is very satisfied with the results and wholeheartedly recommends AKRA TEAM to anyone needing consultation in tricky MDR issues."
January 2024
Elizabeth Gfoeller, MA
Corporate Director, Regulatory Affairs, MED-EL

Dr Ivo Machatschke
Head of Clinical Evaluations R&D, MED-EL
"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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