Sampling Medical Devices for Testing during Unannounced Audits

European Directives and Recommendation 2013/473/EU now require systematic unannounced audits. The Recommendation allows Notified Bodies to sample devices during these audits.

Sampling and testing provisions existed before. However, the systematic approach now challenges both Notified Bodies and Manufacturers. Join LNE/G-MED North America to discuss medical device sampling during unannounced audits.

LNE/G-MED is a leading notified body. We will cover these topics during the webinar:

Regulatory context for sampling during unannounced audits
Company types and devices that require sampling
How Notified Bodies implement these requirements