2 Day Training Course, March 25/26
at 5201 Great America Parkway #254, Santa Clara, CA 95054
For RA/QA Professionals of the Medical Device Industry!
The European Regulations onMedical Devices (includingActive Implantable Medical Devices AIMD)– EU MDR 2017/745 –was published on May 5th, 2017 and entered into force on May 25th, 2017.With May 26th, 2020 as its application date,there is not a lot of time left for Medical Device companies to get up to speed. GMED North America has designed a comprehensive training course to help companies prepare for their application to obtain and/or maintain CE marking for their medical device product(s) and :
- Gain an understanding of the changes introduced by both European Medical Device Regulation – EU MDR 2017/745;
- Assess the impacts of those changes on their organizational and structural activities;
Over the course of 2 days, the attendees will learn about the new requirements to plan an efficient transition and ensure they are ready to:
- Address the new Quality Management System (QMS) requirements;
- Understand the Product Classification criteria’s and Conformity Assessment routes and how it applies to their device(s);
- Assess the impacts on the Technical Documentation for Medical Devices in relation with Product Classification criteria’s and Conformity Assessment routes;
- Identify the expectations with respect to the Clinical Evaluation, Clinical Data(s) and Risk Management;
- Implement the requirements for labelling , the Unique Device Identification (UDI) and EUDAMED;
- Address the expectations with respect to the requirements pertaining to the Post market Surveillance and Vigilance reporting (Periodic reports etc.);
Sign up today and join our intensive 2 day course on the European Regulation for Medical Devices 2017/745 . Acquire a solid foundation so that you and your team are prepared to tackle through practical cases and working sessions/discussions led by our Expert lead auditor, these new challenges.
Keywords: European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Clinical Evaluation and Clinical Data, Post Market Surveillance, Vigilance reporting.
WHO SHOULD ATTEND
- Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R& D specialists, 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 maximum number of participants per training session is set to 15 to guarantee a stimulating and practical working environment.
- Presentations in PDF:
- 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
GMED NA retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.
|About the trainer|