Predetermined Change Control Plan — PCCP (AI-05)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
The Predetermined Change Control Plan (PCCP) — the kit’s flagship document. It defines in advance which model modifications are pre-authorised, the modification protocol and the impact assessment, aligned with both FDA and Health Canada PCCP nomenclature so a single plan can serve multiple markets. The document most often cited as the hardest to draft from scratch for AI/ML devices. Fully editable Word template.
€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.