DIN EN ISO 13485 — Quality management for medical devices
ISO 13485 is the internationally recognised quality management standard for medical device manufacturers and suppliers. It combines conventional quality management with regulatory requirements under the MDR.
What does the standard cover?
The standard requires a quality management system that goes beyond ISO 9001: complete traceability throughout the product life cycle, systematic risk management and documented processes that meet MDR regulatory requirements.
Who is the standard relevant to?
- Medical device manufacturers across all risk classes
- Suppliers whose customers require ISO 13485 certification
- Companies preparing for regulatory requirements under the MDR
Our services
Developing an ISO 13485 quality management system
We develop a quality management system that supports regulatory compliance in your medical device manufacturing or supply processes.
Risk management and traceability
We establish systematic risk management and complete traceability from raw material to finished product.
Certification support
We support you through the certification audit and the notified body's assessment under the MDR.
The certification process
- 1Gap analysis of existing quality processes
- 2Establishing risk management and traceability
- 3Internal audit and documentation review
- 4Certification audit with our support
DIN EN ISO 13485 implementation in your business
We assess your current maturity and draw up a realistic roadmap, free of charge and without obligation.
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