Medical Device Register

For each device family and model it records the identification, classification, UDI, regulatory status, key characteristics, life-cycle status and the location of its Medical Device File.

What's Inside

• Device Families and Medical Device Files
• Device Models and UDI
• Classification and Regulatory Status by Market
• Key Device Characteristics
• Life-Cycle Status and Retention
• Register Change Log
• Review and Approval
• Review and sign-off section

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clauses 4.1.1 and 4.2.3. 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.