Regulatory support

Medace B.V.

The Netherlands

Service ID:

Service description
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 a 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 from beginning to end.
Health and medical care
Technology Readiness Level
TRL 3 – Experimental proof of concept
TRL 4 – Technology validated in lab
TRL 5 – Technology validated in relevant environment
TRL 6 – Technology demonstrated in relevant environment
TRL 7 – System prototype demonstration in operational environment
TRL 8 – System complete and qualified
TRL 9 – Actual system proven in operational environment
Financial requirements