ISO 13485:2016
ISO 13485 Certification
Demonstrate a quality management system fit for medical-device regulation.
Service overview
ISO 13485 specifies requirements for a quality management system where an organisation must demonstrate its ability to provide medical devices that meet customer and regulatory requirements.
AXIOS assessors with medical-device competence review your design controls, risk management and regulatory alignment across the product lifecycle.
Who needs this service
- Medical-device manufacturers and designers
- Suppliers and service providers to the device industry
- Organisations entering regulated healthcare markets
Benefits
- Evidence of a regulation-ready quality system
- Smoother access to regulated markets
- Stronger control of design and production risk
- Confidence for regulators and healthcare customers
Talk to AXIOS about ISO 13485 Certification
Our specialists will help you choose the right scope and plan a clear path to certification or assessment.