✓IndependentObjective assessment and professional expertise.
◎RecognizedStructured around applicable standards and requirements.
↗Business ValueSupports credibility, access and continual improvement.
♧Sector RelevantApplied to the sectors and activities that match your organization.
01 Overview
Quality management system certification for organizations involved with medical devices.
ISO 13485 specifies quality-management-system requirements for organizations involved in the life cycle of medical devices. The emphasis is on regulatory consistency, controlled processes and documented product quality.
02 What we assess
✓Quality-system documentation
✓Design and development controls where applicable
✓Supplier and production controls
✓Traceability and complaint handling
✓Corrective action and regulatory interfaces
03 Key benefits
Supports medical-device quality controls
Strengthens regulatory readiness
Improves traceability and process discipline
Builds confidence across the supply chain
04 Who is it for?
This service is relevant to organizations operating in the following sectors:
Industry & Constructions
Healthcare
International Trade
05 How the process works
1
Application
Submit the application and relevant organizational information.
2
Review
A CERT confirms scope and applicable requirements.
3
Assessment
The required audit, inspection or evaluation is carried out.
4
Evaluation
Results and findings are independently reviewed.
5
Decision
The final certification or service outcome is issued.
06 Standards & Scope
This service is associated with ISO 13485. The final scope and applicable requirements are confirmed during application review.