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This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
Why Should You Attend:
This Medical Device training will be discussing the newly-updated requirements of the Medical Device Directives and their linkage to the European requirements for CE Marking and ISO Certification on commercializing products. The history, current processes and latest regulatory environment on all Classes of Medical Devices and Combination Products will be discussed. Learn how to classify your product and how that classification translates to the required data needed to CE mark your product across the EU. You will also be updated on the recent and changes coming for the two NEW EU Medical Device Regulations, recently announced for final roll-out in 2017.
This course is focused on understanding the requirements of the Medical Device Directives / Regulations, their linkage to the EU Clinical Trial Regulation and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.
Key Topics to be Discussed:
Detailed Agenda of the Session:
Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices in the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.
Who Will Benefit:
This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process. Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.