By : Compliance Online
Date : 2012
Location : California / Palo Alto
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.
Compliance Training on Medical Device Directives, Directives for Medical Devices, Training for Medical Device Compliance
This webinar is focused on understanding 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. 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:
- The current regulatory situation in relation to Medical Devices in the EU.
- The purpose of the Medical Device Directives.
- Meeting the New Requirements for Conformity Assessment by Product Type.
- 2010 Directive Changes; Additional Requirements.
- Understanding the impact the Directive will have on developing and marketing new Medical Device products.
An overview of key areas of the Directive:
- Scope of application and definition
- Essential Requirements
- Medical Device Type & Process Path
- Medical Device Technical File
- Clinical Investigations
- Clinical Evaluations
Instructor : 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.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria