ISO 13485:2016

We're excited to announce the addition of the ISO 13485:2016 Quality Management Systems for Medical Devices framework to our growing list of supported frameworks!

What is ISO 13485?

ISO 13485 is the international standard for establishing and maintaining a quality management system (QMS) specific to the medical device industry. It outlines requirements for all stages of the medical device lifecycle, from design and development to production and post-market surveillance.

Why is ISO 13485 Important?

• Regulatory Requirement: Many countries mandate ISO 13485 certification for medical device manufacturers seeking market approval.

• Quality & Safety: Following ISO 13485 principles ensures consistent quality and safety throughout the medical device lifecycle, protecting patients and enhancing product trust.

• Risk Management: The framework emphasizes risk management practices, helping manufacturers identify and mitigate potential risks associated with their medical devices.

Who needs ISO 13485 compliance?

• Medical device manufacturers of all sizes, from startups to established companies.

• Organizations involved in any stage of the medical device lifecycle, including design, development, manufacturing, and distribution.

If you have any questions or issues, please reach out to your assigned Customer Success Manager. They'll be happy to assist you!

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