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. 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.

MIDI Innovation Vault

MIDI Innovation Vault

Ep 3 Series 11 | Human Factors Regulatory & Guidance Standards for US Submission

MAR 4, 202433 MIN
MIDI Innovation Vault

Ep 3 Series 11 | Human Factors Regulatory & Guidance Standards for US Submission

MAR 4, 202433 MIN

Description

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. 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.