ISO 13485 Insights

What is ISO 13485?

ISO 13485 is an internationally recognized standard for a quality management system (QMS) specific to the medical device industry. It outlines requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is used by medical device manufacturers to ensure the consistent design, development, production, installation, and delivery of medical devices that are safe and effective for their intended purpose.

Find organizations using ISO 13485 on Sumble →

What other technologies are related to ISO 13485?

ISO 13485 Complementary Technologies

ISO 14971

ISO 14971 is a standard for risk management of medical devices and is strongly complementary to ISO 13485 as risk management is a key element of a quality management system.

mentioned alongside ISO 13485 in 76% (2.4k) of relevant job posts

21 CFR 820

21 CFR 820 is the FDA's Quality System Regulation (QSR) for medical devices in the US. It is a complementary standard to ISO 13485 that also addresses quality management systems for medical devices.

mentioned alongside ISO 13485 in 74% (829) of relevant job posts

MDSAP

The Medical Device Single Audit Program (MDSAP) is an audit program recognized by multiple regulatory authorities, including the FDA and regulatory authorities in Canada, Australia, Japan, and Brazil. ISO 13485 is a core element of MDSAP, making them complementary.

mentioned alongside ISO 13485 in 69% (868) of relevant job posts