Module 19 2021

02/06/2021

Post-Production Activity

• Vigilance • Significant changes in the risk-benefit would result in a potential reportable case • Current and active risk management VERY important to determining this • Can provide basic framework for when to report incidents

31

IVD Risk Management

• Pathways is more complex for IVDs • Can be difficult to identify, assess and mitigate risk

Medical Device

Manufacturer

Patient

Physician / Decision Maker

Laboratory/ Operator

Manufacturer

Patient

IVD

32

16