Managing Technical Files and Design Dossiers: Manufacturer and Notified Body Lessons & Perspectives  

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