LRQA and Medtronic spoke to a standing room only crowd at RAPS 2015. You can now download this presentation to learn how compiling and maintaining product Technical Files/Design Dossiers in accordance with the European regulatory requirements can be administered while launching safe medical devices into the market in a timely and compliant manner.
LRQA and Medtronic discussed:
- How to effectively collaborate to achieve the common objective
- How technical documentation is created, managed and submitted from the manufacturer’s standpoint
- An assessor’s outlook on the evaluation of these dossier