Regulatory

With the implementation of the new Medical Devices Regulation (MDR) which replaced the Medical Device Directive (MDD) additional regulatory requirements are introduced to medical device development. Additionally, there is an complex  landscape of (international) regulatory requirements for Advanced Therapy Medicinal Products (ATMPs), an experienced partner is essential to navigate you through these regulatory landscapes.

We employ our experience in medical device and ATMP regulatory affairs to ensure that all of the requisite documentation, certifications and compliance requirements for your product are available. We also train you and your company to complete this registration beginning to end.

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Together with our clients Medace has proven to be successful in this area:

28 Clients (ATMPs and medical devices)

8 certifications granted (ISO/CE and GMP manufacturing licenses)

5 clinical trials started

Regulatory training day for external clients

Medical Device Regulation & Quality Management System – November 2nd 2022

This full-day training workshop is a deep dive into (new) MDR and QMS requirements according to EN ISO 13485:2016. Aimed at researchers aiming to translate their innovation, starting Quality Assurance personnel and entrepreneurs. This training will help you gain in-depth knowledge on key topics, supporting your current or future medical device development.

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