2 days course, July 30/31 - Washington DC area
The new European Union Medical Device Regulation (MDR 2017/745) represents a considerable change from the directives. Medical Device Manufacturers who sells their medical devices in the European Union have taken the necessary steps towards the transition to meet the deadline of May 26, 2020, date that will mark the end of the transition period. This course is a first step towards understanding how to assess the impacts the new regulation implies over your activities and organization. Compliance with the European MDR in a timely manner is the key to implementing it successfully and calls for a structural approach. Over 2 days, attendees will discover and learn about the new requirements to plan an efficient transition and ensure they are ready to address the new Quality Management System (QMS) requirements, the Product Classification criteria’s and Conformity Assessment routes, the impacts on the Technical Documentation for Medical Devices, the expectations with regard to the Clinical Evaluation and Clinical Data, the Unique Device Identification (UDI), and the Post market Surveillance and Vigilance reporting requirements.
Join us for an intensive 2-day course on the European Medical Device Regulation 2017/745 and acquire the solid foundation you and your team need to tackle this new challenge. Through practical cases, working session and discussion with a seasoned lead auditor, prepare for the new Regulation 2017/745.
Keywords: European Medical Device Regulation 2017/745, Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Clinical Evaluation and Clinical Data, Post Market Surveillance, Vigilance.
WHO SHOULD ATTEND
- Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R& D, Development, Manufacturing and Marketing Managers,
- Internal and external Auditors
- Good knowledge and effective practice of the Directives 93/42 / EEC or /and 90/385 / EEC
The number of participants is maximized to fifteen to provide a stimulating and practical working environment.
- Practical working sessions
- Course evaluation
- Lunch meeting with the trainer ( Lead Auditor and Technical File Assessor for high risk devices)
- Understand the Medical Device Regulations approach in Europe
- Know the expectations with the use of the Essential requirements
- Understand how to read the Classification Criteria and Implementation rules
- Learn how to identify:
- the applicable conformity assessment routes for your device(s),
- the impacts on the Technical Documentation
- The expectations and requirements with regard to Clinical Data and Clinical Evaluation
- Post market surveillance and reporting requirements in the MD
|Training content and objectives|
|DAY 1 & 2: EU Medical Device Regulations|
|8:30 am to 9:00 am||Breakfast|
|9:00 am – 12:15 pm||
|12:15 pm - 1:00 pm||Lunch|
|1:00 pm- 5:00 pm||
Program + Practice session
LNE/G-MED NA retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.
|About the trainer|