Design and Development Control — Process Package (ISO 13485)

Design and Development Control — Process Package (ISO 13485)

€69.00

SKU ISO-15 Category Tags , , , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

Process Package

Complete design control system covering ISO 13485 §7.3, EU MDR Annex I + II, 21 CFR 820.30 / FDA QMSR. End-to-end DHF (Design History File) infrastructure.

What’s included:

  • SOP-ISO-15 Design and Development Control — full design lifecycle (Concept → Feasibility → Inputs → Outputs → V&V → Transfer → Launch), 6 phase gate reviews.
  • F-ISO-15.1 Design Plan (Word) — per-project Design Plan with phases, deliverables, reviews, DHF.
  • F-ISO-15.2 I/O Matrix (Excel — 5 tabs) — bidirectional traceability Design Input → Output → Verification → Validation. 10 sample inputs across 8 categories + 7 full traces.
  • F-ISO-15.3 Design Review Record (Word) — per phase gate review.
  • F-ISO-15.4 Design Verification Protocol & Report (Word) — combined V protocol + report. 7 V sections (Sterilization, Transport, Aging, Biocompat ISO 10993, Performance, Electrical IEC 60601, Software IEC 62304).
  • F-ISO-15.5 Design Validation Protocol & Report (Word) — combined Validation. 5-approach selector. Production-equivalent units. 15+ participants per FDA HFE 2016.
  • F-ISO-15.6 Design Transfer Checklist (Word) — Hardware + Software (per IEC 62304) + System type-specific (Mobile / Embedded / SaMD).

Why this package: Design Control is the #1 reason FDA cites manufacturers. This package gives you a complete, audit-ready DHF infrastructure for any device class including SaMD.

Format: Microsoft Word | Excel (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase

€69.00

Related products

Picture of Alessandro Stella

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.