DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "An Introduction to the Medical Devices Directives" conference to their offering.
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.
This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.
An Introduction to the Medical Device Directives - this course will help you gain a comprehensive understanding of the regulatory requirements.
Benefits Of Attending
- 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
Programme Day One
What is a Medical Device?
Europe and the Medical Device Directives
- What is a Competent Authority, Notified Body and an Authorised Representative?
- How do they inter-relate?
- Responsibilities of each party
Classification of Devices
- Review of definitions
- The 18 rules
Conformity Assessment Procedures
- Optional routes for each class
- What is required for each class
Workshop 1: Classification
End of Day One
Programme Day Two
- Technical file and design dossier requirements
- EN ISO 13485
- The requirements for a quality system
- European Regulatory environment
- When are Clinical Investigations necessary?
- What is required by the Competent Authorities, Ethics Committee and Notified Body?
Workshop 2: Clinical Evaluations
Medical Device Vigilance
- Adverse Event reporting
- Reporting requirements
- Post Market Surveillance (PMS)
Workshop 3: Vigilance
End of Day Two
Programme Day Three
Labelling of Devices
- Use of language and symbols
- Instructions for use
Workshop 4: Labelling
- Drug or device?
- Examples of classification
Devices Incorporating Material of Animal Origin
- Animal derived material legislation
- Directive 2003/32/EC
The Draft Proposed Revision to the Regulations for Medical Devices and In-Vitro Diagnostics
End of Conference
For more information about this conference visit http://www.researchandmarkets.com/research/9wc59r/an_introduction