Defining FDA ISO 13485

[Shalini]

In May 2018, FDA first proposed revising its current Quality System Regulations (QSR) under 21 CFR Part 820 to more precisely align with the international ISO 13485:2016 standard as the basis for its quality system legislation. This signals an essential step forward for the international standard, which is already used globally. FDA ISO 13485 QMS standard for medical devices enables controlling processes to ensure that the end product meets the desired quality and safety requirements.