EU-MDR Technical File Authoring
Introduction
Medical Technology Client
Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices.
Apotech Consultants
Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your organisation.
Standards & Tools
- EU-MDR 2017-745
- ISO 13485
- ISO 14971
- IEC 62366
- GDPR
- Word Excel, PowerPoint
Scope of work
13 Technical files converted from MDD to MDR, Class IIa to Class III
Literature review & CER authoring
Produced plans for post-market surveillance and Post-market clinical follow-up
Internal and external auditing support
Gap Assessment and device diagnostics report
Updated Risk Management Procedure
Submission to BSI as the notified body
Address questions/facilitate discussion and follow-up with BSI
Key numbers
Team
4.5 FTE
Location
USA
Length
3 months
Type
Work Package