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ISO 13485:2016

Last updated May 16, 2025, generated by Sumble

What is ISO 13485:2016?

ISO 13485:2016 is an internationally recognized standard that specifies requirements for a quality management system (QMS) specific to the medical device industry. Organizations use it to demonstrate their ability to consistently meet customer and regulatory requirements applicable to medical devices and related services. It covers all stages of a medical device's lifecycle, from design and development to production, installation, and servicing. Certification to ISO 13485 is often required for companies seeking to market their medical devices in various global markets.

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What other technologies are related to ISO 13485:2016?

ISO 13485:2016 Complementary Technologies

ISO 14971:2019

ISO 14971:2019 is a standard for applying risk management to medical devices. It's strongly complementary to ISO 13485:2016, which focuses on quality management systems, as risk management is an integral part of ensuring product safety and effectiveness.

mentioned alongside ISO 13485:2016 in 74% (95) of relevant job posts

MDSAP

MDSAP (Medical Device Single Audit Program) is a program that allows medical device manufacturers to be audited once for compliance with the regulatory requirements of multiple countries. It complements ISO 13485 by streamlining the auditing process for global market access.

mentioned alongside ISO 13485:2016 in 9% (112) of relevant job posts

21 CFR 820

21 CFR 820 is the FDA's Quality System Regulation for medical devices, which outlines current good manufacturing practice (CGMP) requirements. It is complementary to ISO 13485:2016, as both aim to ensure quality and regulatory compliance in medical device manufacturing, but 21 CFR 820 is specific to the US market.

mentioned alongside ISO 13485:2016 in 8% (93) of relevant job posts