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UNDERSTANDING THE EUROPEAN DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES (COURSE CODE:IS/9)
Course Objective & Benefit
Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of EU regulation on medical devices. The course will cover the general context for the directive, product classification, and the routing in getting CE certification. Included with this course are extensive course notes that are frequently used by attendees as reference material once the course is completed.
Course Outline
The workshop focusing on understanding the requirements of the Directives, the requirements of CE Marking and ISO Certification on commercializing products. The Course covers all relevant topics 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
- An overview of key areas of the Directive:
- Scope and field of application and definition
- Essential Requirements
- Medical Device Type & Process Path
- Medical Device Technical File
- Notified Bodies
- Gain a detailed understanding of all Guidance Documents available to assist in implementation of these directives
Who Should Attend
Because of its comprehensive overview, this course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, and quality engineers, whether in product development, manufacturing, quality assurance, or regulatory affairs, who are new to the industry or to their current position and do not have an in-depth knowledge on medical device regulation.
About the Facilitator
The tutor is registered ISO 13485 Lead Auditor, CMDCAS Auditor, JPAL Auditor.
He has audited over 50 organizations on Medical Device Certification.
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