Strategy for Regulatory Compliance — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete regulatory strategy system covering EU MDR Art. 15 PRRC requirements, MDCG 2019-7 Rev.1 (PRRC guidance), and broader regulatory strategy framework.
What’s included:
- SOP-ISO-20 Strategy for Regulatory Compliance — multi-jurisdiction strategy, PRRC role, regulatory intelligence cycle.
- F-ISO-20.1 PRRC Qualification Record (Word) — Art. 15(1)(a) education+experience OR (b) 4-years experience pathway, MDCG 2019-7 knowledge areas (9 areas), continuous availability declaration.
Why this package: PRRC is mandatory for CE-marked devices. NB inspectors verify PRRC qualification documentation. This package gives you defensible documentation aligned with Art. 15.
Format: Microsoft Word (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€69.00
Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.