Industry
Medical devices
ISO 13485 structures the whole device life cycle: design, production, surveillance and risk control.
Industry challenges
- Risk management across the life cycle.
- Technical file and product traceability.
- Control of critical production processes.
- Post-market surveillance.
Regulatory context
ISO 13485 requirements and applicable medical device regulatory expectations.
Our approach
- 01ISO 13485 diagnostic and gap analysis.
- 02Structuring risk management.
- 03Certification audit preparation.