FMEA Technique for Risk Analysis
FMEA (Failure Mode Effect Analysis) is definitely the most widely used method for assessment of risks associated two any type of devices and processes. This is valid for any type
New ISO 14971: Updates for Risk Management
ISO 14971 for medical device risk management was approved in December 2019. Although no significant changes on the risk management process was defined, a substantial re-organization of the standard was performed.