Production and Service Provision — 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 production system covering ISO 13485 §7.5, 21 CFR 820.181 (DMR), MDSAP Chapter 5. Process step-driven DHR (Device History Record) generation.
What’s included:
- SOP-ISO-24 Production and Service Provision — controlled production, in-process inspection, traceability, DHR.
- F-ISO-24.1 Manufacturing Process Specification (Word) — equivalent to FDA DMR per 21 CFR 820.181: Site, BOM, Specifications, 10-step Process Steps with CPP+IP inspection+operator qualification, DHR content checklist, Final release criteria.
Why this package: DMR/MPS is foundational. Without it, DHR generation breaks down. This package gives you a defensible production specification.
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
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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.