Design and Development Plan
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Plan
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Plan
A Design and Development Plan template for planning and controlling the design of a medical device, covering the project overview, design stages and schedule, design reviews, verification, validation and transfer activities, responsibilities and interfaces, as required by ISO 13485:2016, Clause 7.3.2. It comes with a completed worked example.
What's Inside
- Project Overview
- Design and Development Stages and Schedule
- Design Reviews
- Verification, Validation and Transfer Activities
- Design Verification (clause 7.3.6)
- Design Validation (clause 7.3.7)
- Design Transfer (clause 7.3.8)
- Responsibilities and Authorities
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.3.2. It fits with the rest of the QEHS Vault ISO 13485 document set.
Format
Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
Reviews
There are no reviews yet.