CE Marking: MDD, AIMDD and IVDD
June 19, 2013
Location
san Francisco
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
USA
Description
Description:
This webinar is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices.
This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directives, which help assure that medical devices are safe and effective for their intended use.
Understanding the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, resulting in saving significant amount of time, efforts and resources and bringing innovative medical products to the EU market faster. This webinar will discuss EU Directives, requirements including postmarket requirements and compliance. At the end of the webinar, you will get familiarized with the applicable EU Directives governing medical devices including in vitro diagnostic and active implantable medical devices.
Objectives of the Presentation:
How EU laws are made
Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices
Medical Device Directive (MDD)
Active Implantable Medical Device Directive (AIMDD)
In Vitro Diagnostic Device Directive (IVDD)
2007/47/EC Amending MDD and AIMDD
CE Marking Principles
Device Classification
Additional Information
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.
Organized by
online compliance panel
38868 Salmon Ter, Fremont California 94536
san Francisco, California 94536
United States of America
More Information
Contact: martin luthur
Email: onlinecompliancepanel1@gmail.com
Phone: +1-510-857-5896
Event's Website
