It’s quite easy to mix up the Failure Mode and Effects Analysis (FMEA) from IEC 60812:2018 and the Hazard Traceability Matrix (HTM) in the ISO 14971:2019. Especially since nothing prevents a company from using these terms interchangeably or using different terms...
The Life Science Industry is known for a vast number of regulations and various sets of guidelines that organizations must comply with. One regulatory framework that is applicable to many Life Science organizations is FDA 21 CFR Part 11. A regulation that governs how...
