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Medical Device Regulatory Consulting FAQ

Common questions about PRRC services, FDA Agent appointments, and medical device compliance consulting.

• Do I need a PRRC for EU medical device compliance?

  Yes, all EU medical device manufacturers must appoint a PRRC under Article 15 of the EU MDR/IVDR. Micro and small companies can outsource this role to qualified external consultants rather than hiring full-time staff. The PRRC handles conformity assessment, technical documentation, post-market surveillance, and regulatory correspondence.

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• What is a US FDA Agent and when do I need one?

  A US FDA Agent is required for all foreign medical device manufacturers selling in the United States. The Agent serves as your official US point of contact for FDA communications, enforcement actions, and regulatory correspondence. This is mandatory for device registration and listing, not optional.

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• How quickly can PRRC and US FDA Agent services start?

  Both PRRC and US FDA Agent services typically start within 3-5 business days after completing our onboarding checklist. You receive the formal appointment documentation, responsibility matrix, and communication workflows immediately upon activation. Emergency appointments can be expedited for distributor deadlines or audit requirements.
• Can you help if we don't know our medical device classification?

  Absolutely. Device classification is part of our initial regulatory strategy assessment. We analyze your intended use, clinical evaluation requirements, and applicable standards to determine the correct EU MDR/IVDR class or FDA product code. You'll receive a clear regulatory pathway with no guesswork.
• Do you perform ISO 13485 and MDR internal audits?

  Yes, we conduct internal audits against ISO 13485, EU MDR requirements, and US FDA QMSR. Our audits identify gaps before notified body or FDA inspections, provide corrective action plans with clear ownership, and deliver audit-ready evidence packages. We also offer coaching to help your team close findings effectively.
• How are medical device consulting fees structured?

  PRRC and US FDA Agent services are retainer-based with monthly fees and defined SLAs. Project work (regulatory strategy, audits, submissions) uses fixed-fee proposals with clear deliverables and timelines. We provide detailed cost breakdowns before any engagement begins—no surprises or scope creep.