Mark

Just Launched: UserWise University - Browse our new elearning courses!

Click here to learn more.




Resource Library






FDA & ISO Issued Documentation


HTML Table Generator
Document
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices (2016) ︎
ISO 14971: Application of risk management to medical devices (2019) ︎
FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (2016) ︎
IEC 62366-1: Application of usability engineering to medical devices (2020) ︎
Mark

UserWise, LLC
Office Hours
Monday-Friday 9:00 AM - 5:00 PM PT


Copyright © 2022 UserWise, LLC. All rights reserved.