ISO 13485
What is ISO 13485?
ISO 13485 is the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. It defines requirements for companies that develop, manufacture, assemble, or service medical devices – with the goal of ensuring the highest levels of quality, safety, and reliability.
A quality management system in accordance with ISO 13485:2016 helps you identify and monitor critical points throughout all phases of the product life cycle – from development and production to traceability and servicing. This ensures that your products meet legal and regulatory requirements while also exceeding customer expectations.
We recommend ISO 13485 certification to all companies that are part of the medical device supply chain – regardless of whether they manufacture devices directly, supply components, or provide services in the medical environment.
ISO 13485 Requirements
A certified quality management system for medical devices includes:
- Introduction of extended requirements for medical organizations
- Definition, documentation, and monitoring of compliant processes
- Validation and traceability of all production processes
- Continuous improvement of quality management
- Training of personnel on regulatory and quality-related topics
Benefits of ISO 13485 Certification
- Ensuring product quality throughout the entire supply chain
- Compliance with legal requirements (e.g. MDR, IVDR, national regulations)
- Strengthened customer confidence and support for market approval
- Increased competitiveness through internationally recognized certification
- Effective risk management and early identification of potential weaknesses
- Better cooperation with partners and authorities
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Would you like to have your quality management system for medical devices certified in accordance with ISO 13485? Contact us – we will provide individual advice and support you on the way to greater quality, safety, and regulatory compliance.
