Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes 2016 is a webinar that covers topics such as:
- IVD, MDD & Active Implantable Directive
- New approach directives & background
- Competent Authorities & Notified Bodies
- Impact of significant recent & proposed changes
- Device classification
- Medical Device Directive vs. Regulation vs. ISO 13485
- Technical files vs. Guidance Documents
- Routes to CE marking under various MDD annexes
- Essential requirements
Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes 2016 is intended for attendees from:
- Manufacturing & Design Engineers
- Quality & Regulatory Professionals
- Program Managers
- Marketing Product Managers
