An excerpt of the Medical Device Innovations Section of the US Law PLAW-114Publ255 referred to as the “21st Century Cures Act” and published in December of 2016 is at the link provided. There are many important elements of this law, including how accessories are classified and what software functions are not outside the definition of...Read More
The FDA maintains a dedicated webpage to provide ongoing information on FDA’s digital health initiative.Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.