Device Master Record
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
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
A Device Master Record (DMR) template that brings together, for each device type or family, everything ISO 13485:2016, Clause 4.2.3 requires: device description, intended use and labelling, product specifications, manufacturing process, packaging, storage and distribution, measuring and monitoring procedures, installation and servicing, production environment and device history record requirements, with a completeness checklist.
What's Inside
- Device Identification
- Description, Intended Use and Labelling
- Product Specifications
- Manufacturing Process
- Packaging, Storage, Handling and Distribution
- Measuring and Monitoring Procedures
- Installation and Servicing
- Production Environment and Contamination Control
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.5.1. 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
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