DUBLIN--(BUSINESS WIRE)--The "An Introduction to the Medical Device Regulation" conference has been added to ResearchAndMarkets.com's 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.
Agenda
Day One
09.30 Welcome and introduction
09.45 What is a medical device?
- Definition
- Examples
10.45 Discussion
11.00 Refreshments
11.15 Europe and the Medical Device
- Regulation - overview of the regulations applicable for bringing a medical device to market
12.15 Discussion
12.30 Lunch
13.30 What is a Competent Authority,
- Notified Body and an Authorised Representative?
- How do they inter-relate?
- Responsibilities of each party
14.30 Classification of devices
- What are the classes and how do we classify devices
15.15 Discussion
15.30 Refreshments
15.45 Conformity Assessment Procedures
- The routes to CE marking
- What is required for each class of device
16.30 Workshop 1: Classification
16.45 Discussion
17.15 End of day one
Day Two
09.00 Manufacturer's responsibilities
- Technical file and design dossier requirements
10.00 Quality systems
- EN ISO 13485: 2012 and 2016
- The requirements for a quality system
10.45 Discussion
11.00 Refreshments
11.15 Labelling of devices
- Use of language and symbols
- Instructions for use
12.15 Discussion
12.30 Lunch
13.30 Workshop 2: Labelling
14.15 Discussion
14.30 Clinical evaluations
- European regulatory environment
- When are clinical investigations necessary
- What is required by the Competent Authority, Ethics Committee and Notified Body
15.30 Discussion
15.45 Refreshments
16.00 Workshop 3: Clinical evaluations
16.45 Discussion
17.00 End of day two
Day Three
09.00 Medical device vigilance
- Adverse event reporting
- Reporting requirements
- Post Market Surveillance (PMS)
10.00 Workshop 4: Vigilance
10.45 Discussion
11.00 Refreshments
11.15 Drug/Device combinations
- Drug or device?
- Examples of classification
12.15 Discussion
12.30 Lunch
13.30 Devices incorporating material of animal origin
- Animal derived materials legislation
- Directive 2003/32/EC
14.30 Discussion
14.45 Refreshments
15.00 The revision to the regulations for medical devices
15.45 Question and answer session
16.00 End of seminar
For more information about this conference visit https://www.researchandmarkets.com/research/tph72l/3day_course_an?w=4
