Medical Risk-Based Testing
with IEC60601-1 3rd Edition
by Ops A La Carte, part of the Ops monthly webinar series.
Friday December 2nd, 8:30-9:30am PST
The medical industry is moving in a similar direction to many other industries – Risk Based Testing. We will discuss what this means and how to comply. We will highlight each of the clauses in the document and help you decode what each means and how to comply. But more than that, we will show you how to change your approach to testing so that any test you consider, you think of the risks involved before you plan out the test.
It starts with Risk Management (work with Notifying Body / Test House, Regulatory Agencies, Regulatory Affairs Department). FMECAs, FTAs, Fishbone, etc. (Hazards & Risks). Use, Design, Process, and Software FMECAs are typically used as well as System Hazard Analyses. ISO 14971:2009 Application of Risk Management to Medical Devices also plays a big part.
Register at: https://www2.gotomeeting.com/register/634001930