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Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
Friday, June 29, 2012 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
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 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.
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:
- Clinical research and medical operations
- Project Managers
- Product Development personnel
- Manufacturing personnel
- Researchers managing Medical Device R&D and Development
- Quality Assurance such as GMP, GCP Auditors
- Regulatory affairs
- Clinical trial supply personnel
- CRO personnel
- All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (25 expanded countries)
For Registration :
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.