Safety & Compliance in accordance with MDR
The EU Medical Device Regulation (MDR, Article 15) stipulates that manufacturers and authorized representatives must appoint a person responsible for regulatory compliance (PRRC).
This function is mandatory for MDR compliance and includes:
- We monitor product compliance in accordance with MDR.
- We ensure that technical documentation and conformity assessment are carried out.
- Regulatory review of market surveillance (PMS & Vigilance) is mandatory.
- We work closely with the notified bodies and authorities.
As an external PRRC, we take on this responsibility for your company. We train your employees to build internal expertise. With our expertise, we ensure that your medical devices comply with the latest regulatory requirements – legally compliant, efficient, and practical.
Ensure regulatory certainty now with a qualified PRRC at your side.