Greg Montalbano takes our listeners on a deep dive as related to the Human Factors Regulatory Standards and Guidance documents for US submission.

This episode specifically covers topics as related to the various organizations and regulatory bodies as well as standards and guidance documents to utilize for proper usability research and human factors engineering processes during medical device design and development.  More specifically, learn more about:

• What organizations have issued United States Regulatory and Guidance documents for Human Factors as related to medical device development.

• The U.S. Standards and Guidelines that apply to certain medical devices types.

• Organizations and their issued international regulatory standards of human factors for medical devices, of which are recognized by the FDA and the AAMI.