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:

15 Clients (ATMPs and medical devices)

2 ISO certifications granted in 2018

1 GMP manufacturing license granted in 2018

2 clinical trials running in 2018

1 multi-center trial starting in Q3 2019

Other capabilities