What is ISO 13485? It's the internationally recognized standard specifying quality management system requirements for organizations involved in the lifecycle of medical devices, including design, manufacturing, and servicing.

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Companies seeking to demonstrate their ability to consistently provide medical devices and related services that meet customer requirements and applicable regulatory requirements pursue ISO 13485 certification. The core objective of ISO 13485:2016+A11:2021 is to streamline global medical device regulatory requirements concerning quality management.

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This standard incorporates specific needs for the medical device industry while excluding certain ISO 9001 requirements deemed less relevant for regulatory purposes.

 

The significant benefits of ISO 13485 include greater access to worldwide markets, enhanced operational efficiency, increased employee competence and industry understanding, a structured method for meeting regulations and customer expectations, guaranteed compliance with regulatory bodies, the assurance of providing safe and effective products, and robust risk management practices.