Dublin, Sept. 13, 2022 (GLOBE NEWSWIRE) -- The "An Introduction to the Medical Device Regulation Training Course" conference has been added to ResearchAndMarkets.com's offering.
This seminar provides an invaluable overview of the European Medical Device Regulation (MDR). The interactive programme will explain the new legislation and which products are covered, the involvement of Notified Bodies and how to choose one and will outline a manufacturer's responsibilities. 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 days of intensive training.
Who Should Attend:
Past delegates include those working in regulatory affairs, pharmacovigilance, quality assurance and technical support. This event will be of particular interest to all personnel who are new to the medical device industry, all those who intend to place a medical device on the market and anyone who requires an overview of the medical device sector.
Key Topics Covered:
What is a medical device?
- Definition
- Examples
Europe and the MDR - overview of the regulations applicable for bringing a medical device to market
Economic operators and other parties
- Who are they?
- How do they interrelate?
- What are their responsibilities?
Classification of devices
- What are the classes and how do we classify devices?
Conformity assessment procedures
- The routes to CE marking
- What is required for each class of device?
Workshop 1: Classification
Manufacturers' responsibilities
- Technical file and design dossier requirements
Quality systems
- EN ISO 13485: 2012 and 2016
- The requirements for a quality system
Labelling of devices
- Use of language and symbols
- Instructions for use
Workshop 2: Labelling
Clinical evaluations
- European regulatory environment
- When are clinical investigations necessary?
- What is required by the competent authority, Ethics Committee and Notified Body?
Workshop 3: CE marking
Medical device vigilance
- Adverse event reporting
- Reporting requirements
- Post-market surveillance (PMS)
Workshop 4: Vigilance
Drug/device combinations
- Drug or device?
- Examples of classification
Devices incorporating material of animal origin
- Animal-derived materials legislation
- Directive 2003/32/EC
The revision to the regulations for medical devices
For more information about this conference visit https://www.researchandmarkets.com/r/k5piaq
