Familiarize yourself with the basics of medical device testing. This book is a good resource for real world examples of how HF is applied to evaluating the safety of med devices: https://www.amazon.com/Medical-Device-Use-Error-Analysis-ebook/dp/B01A8TCCOE/ref=nodl_?dplnkId=1e463b39-9ac5-4dbe-85f2-68b9057d38dd
I’d check it out of your local library if they happen to have it and give it a read.
Also reading the ANSI: https://webstore.ansi.org/standards/aami/ansiaamiiso134852016 if you can’t find it online I can probably email you a copy. It’s has everything you need to know. I work in the field and reference it a lot.