Join LNE/G-MED for its popular and informative 1.5-day training, Contents of a Technical File: Requirements of Medical Devices Directives 93/42/EEC and 90/385/EEC for CE marking.  

Learn about the different elements you need to build the technical documentation to show conformity of your medical devices to the Directives' requirements and develop a methodology allowing you to structure your technical file. This information can help you better respond to the Notified Bodies' and competent authorities' expectations. In this in-depth and interactive training you can ask our experts questions and discuss among peers in working groups to gain a complete picture of the technical file. Participants will learn what notified bodies look for, the regulations governing technical files, and how a well-constructed technical file is important to their device's CE marking. Regardless if you've built a lot of technical files, you haven't built any, or you have a new device that needs a technical file, the small class size will help you learn from the instructor and your peers to build a well-constructed technical file. 

Register now or call us at (301) 495-0477 so you don’t miss out on this important information!

Place and Time

• Feb. 28-29, Rockville, MD

Program

• Technical Documentation: Goals of the technical documentation; Regulations, guidance documents and recommendations; Link between the documents and the quality system actors; Technical File Contents: detailed review of the requirements.
• Structure and Management of a Technical File: Developing a structure and summary of the technical file; Examples of technical file structure; Technical file management: responsibilities and updates; CE Declaration of Conformity: contents and updates; G-MED guide “Technical File – Information to be provided.”

Who Should Attend

• RA/QA Professionals, Medical Device Manufacturers, Original Equipment Manufacturers (OEM), Manufacturers using Own Brand Labeling procedure (OBL), Anyone who must compile technical files or design dossiers.

Prerequisites: general knowledge of the medical device regulation, basics on CE marking requirements for CE marking

Tuition

$899 ($845 if enrolled prior to February 1st)

Tuition includes all materials and exercises, breakfast for two days, one lunch and one break.