Demystifying Medical Device Regulatory Frameworks

In this video, we address device classifications, software safety classifications, and level of concern, as it relates to medical device development. We discuss each framework and how each is classified and what each classification means and determines in the product development process, and more specifically, what is required for a 510(k) or PMA submission.

Resources:
CFR - Code of Federal Regulations Title 21- www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/C…

IEC 62304 - www.iso.org/standard/38421.html

ISO 14971 - www.iso.org/standard/38193.html

IEC 60601 - www.iso.org/standard/65529.html