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?
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
Technical file and design dossier requirements
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
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
Post-market surveillance (PMS)
Workshop 4: Vigilance
Drug or device?
Examples of classification
Devices incorporating material of animal origin
Animal-derived materials legislation
The revision to the regulations for medical devices
For more information about this conference visit https://www.researchandmarkets.com/r/k5piaq
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