PRRC Services for MDR & IVDR Compliance

PRRC Services for MDR & IVDR Compliance

Ensure full compliance with EU MDR and IVDR Article 15 by partnering with our experienced Person Responsible for Regulatory Compliance (PRRC) service from Regulatus. We provide expert oversight, ensuring your medical devices meet all regulatory obligations.

Our PRRC services include:

• Regulatory Compliance Assurance: Audit services to ensure you product release procedures comply with MDR and IVDR requirements.
• Document Review & Maintenance: Overseeing technical documentation and post-market surveillance, including vigilance.
• Risk Management Support: Ensuring compliance with quality and safety standards.
• Expert Guidance: Access to experienced professionals with deep knowledge of EU regulations.

Stay compliant, mitigate risk, and confidently meet EU regulatory demands with our trusted PRRC service. We can offer outsourced PRRC service to small and micro sized companies both inside the EU and outside the EU