CE Marking of Medical Devices – A Step-by-Step Guide for Compliance
$279.00 – $2,550.00
In this course, the instructor will give you a step-by-step process for preparing a Technical File or Design Dossier that is compliant with the current regulations and the proposed Annex III of the new European Medical Device Regulation.
In this course, the instructor will give you a step-by-step process for preparing a Technical File or Design Dossier that is compliant with the current regulations and the proposed Annex III of the new European Medical Device Regulation. The course will review available guidance documents and the proposed Annexes–including Essential Requirements (Annex I), Declaration of Conformity (Annex III) and the overall Technical Documentation (Annex II).
- MDD 93/42/EEC-Articles 1-23
- Device Classification
- Conformity Assessment Procedures
- Notified Body Selection
- Technical File vs. Design Dossier
- Essential Requirements, Annex I
- Authorized Representatives
- Types of CE Certificates
- Declaration of Conformity
- Post-Market Design Changes
- Maintaining Your Technical File
WHO SHOULD ATTEND
This course will be of benefit to anyone preparing regulatory submissions for CE Marking of medical devices. Additionally, anyone that is working with on verification and validation testing of medical devices would benefit from knowing how that testing information needs to be documented for a CE Marking submission.
WHAT TO EXPECT
HOW TO PARTICIPATE
This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.
THE TRAINING PLATFORM
Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.
Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.
Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.
Single Participant, 5 Participant Value Package, 10 Participant Value Package