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Recorded Webinar
Medical Device Regulations in EU and CE-Marking
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
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 and efforts and bringing innovative medical products to the EU market faster.
This webinar will discuss EU Directives, 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.
The presentation will cover the following areas:
- 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
- ISO 13485, ISO 14155, and ISO 14971
- GHTF and MEDDEV guidance documents
Who should attend
Anyone who is interested in learning more on FDA Medical Device Regulations
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