Medical Device Classification Record

This record documents the regulatory classification of a medical device or device family for every market in which your organisation places, or intends to place, it on the market. It records the inputs, the classification rules applied, the rationale, the resulting class and conformity assessment route, and the consequences for the QMS.

What's Inside

• How to complete this record
• Device Identification
• Classification Inputs
• EU MDR Classification (Regulation (EU) 2017/745)
• USA FDA Classification (21 CFR Parts 862–892)
• Singapore and Malaysia Classification
• Other Markets
• Classification Summary and QMS Impact

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clause 4.1.1. 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.