IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. This standard was last reviewed and confirmed in 2021, remaining current.
Trusted By Notified Bodies & Global Brands
WHAT'S NEW
Transformational Training for ISO Standards, Auditing & Medtech QA/RA
Our team has you covered with expert insights & updates to stay on top of the latest updates, trends, and changes in the industry.
Global
Ireland
Finland
United Kingdom
United States