DUBLIN--(BUSINESS WIRE)--The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's offering.
This course will help you gain a comprehensive understanding of the regulatory requirements.
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark.
- Learn the role of a Notified Body
- Know what a Competent Authority expects
- Better under Conformity Assessment Procedures, Classification, Medical Device legislation
- Comply with Manufacturing Responsibilities
- Consider the requirements for Quality Systems
- Plan your Clinical Evaluations
- What is a medical device?
- Europe and the Medical Device
- What is a Competent Authority?
- Classification of devices
- Conformity Assessment Procedures
- Workshop 1: Classification
- Manufacturer's responsibilities
- Quality systems
- Labelling of devices
- Workshop 2: Labelling
- Clinical evaluations
- Workshop 3: Clinical evaluations
- Medical device vigilance
- Workshop 4: Vigilance
- Drug/Device combinations
- Devices incorporating material of animal origin
- The revision to the regulations for medical devices
- Q&A session
For more information about this conference visit https://www.researchandmarkets.com/research/7wbqpk/3_day_seminar_an?w=4