By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: December 15th, 2014
The new Regulatory Framework for medical devices currently being considered in the European Union will no doubt bring about many significant changes to manufacturers. These changes will encompass stringent Notified Body requirements and oversight coupled with increasing Notified Body authority. These changes will in turn affect your audit experience.
- 10000Did you miss our recent webcast "Updating Technical Files - Is Your Company Ready for a Notified Body Audit?" Listen to it here!
- 10000By Ron Sills, M.S., Nerac Analyst, Originally Published: October 3rd, 2014 Is your company ready for an audit by your notified body? Medical device manufacturers who market devices in Europe (or plan to) must undergo a rigorous certification process through a notified body, who are authorized on behalf of the European Union to ensure that…
- 78By Ron Sills, M.S., Nerac Analyst Originally Published: June 22nd, 2015 Nerac was approached by several medical device manufacturers after receiving formal citations by their notified bodies for non-conformities in their clinical evaluation reports, specifically pertaining to the state-of-the-art analysis for their products. This state-of-the-art requirement is specified in the MEDDEV 2.7.1 Rev. 3 document,…