Systematic unannounced audit are now broadly implemented following the European Directives requirements and Recommendation 2013/473/EU. One of the provisions of the Recommendation relates to the sampling Notified Bodies could perform during their unannounced audits.
Although the sampling and testing possibility is not new, the provisions of the recommendation create a unique challenge for both the Notify Body and the Manufacturer as it is now becoming systematic. Join LNE/G-MED North America to discuss on Sampling of Medical Devices during Unannounced Audits.
As a leading notified body, LNE/G-MED will cover the following topics during this webinar:
- The regulatory context surrounding the need for sampling during Unannounced Audit
- Company type and or devices for which sampling may apply
- A Notified Body's perspective of the requirements' implementation