Person Responsible for Regulatory Compliance (PRRC)
PRRC is a mandatory role under EU MDR and IVDR, requiring a qualified person to oversee compliance and post-market activities.
Apotech Consulting France can act as your PRRC, supporting both EU-based and international manufacturers with:
- Ongoing regulatory compliance
- Post-market surveillance and vigilance oversight
- Device manufacturing and lifecycle control
- Qualified EU representation for non-EU manufacturers
Outsource your PRRC role to Apotech for full regulatory coverage.
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Our Global Representation Reach
We are dedicated to our clients’ global expansion. With consultants in situ in every major economy, we are well equipped to support your global expansion from a technical standpoint and facilitating local representation.
Apotech is a registered UK Responsible Person (‘UKRP’) for those looking to sell their devices in the UK, and a European Union Authorized Representative you were looking to gain a CE Mark in the EU.
Added to this, work with us to benefit from our combined 15+ years of tried and tested relationships with representative partners globally. Click your desired country below to see how we can support your global expansion…