by Jonathan Amaya-Hodges | Sep 12, 2023 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed Have you reviewed the FDA’s final guidance on human factors for combination products?  Our team of CP experts have made a cheat sheet of key points...
by Jonathan Amaya-Hodges | Dec 12, 2022 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed INDUSTRY NEWS BRIEF: New Draft Guidance on Content of Human Factors in Medical Device Marketing Submissions The FDA recently published new...
by Steve Badelt | Jul 13, 2020 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdomthat will help you succeed Reducing Medication Error: Systems Approach, Human Factors & Usability Testing It is currently estimated that over 250,000 deaths from medical...
by Steve Badelt | Feb 14, 2020 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdomthat will help you succeed HF 101: What is Human Factors? The International Ergonomics Association (IEA) definition of human factors, also adopted by the Human Factors and...
by Lori Skope | Jun 4, 2019 | Blog
Combination Product Industry News & Guidance Sharing device-related information and wisdom that will help you succeed How To Write a Human Factors/Usability Engineering Report for FDA Approval Every combination product or medical device submitted to the FDA requires...
