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Medical Device Regulation in the US and EU (Synchronous e-learning)

Name: Medical Device Regulation in the US and EU (Synchronous e-learning)
Price: 1620.00 SGD
Rating: 4.4 (19 reviews)

Training Provider: NATIONAL UNIVERSITY OF SINGAPORE

Course Reference: TGS-2020507245

S$1,620

Original: S$5,400

Save S$3,780

About This Course

"The module delves into medical device regulation in the US, with an emphasis on the product lifecycle and an extended examination of the submissions process in the US. Key sub-topics include interactions with the US Food and Drug Administration (FDA), submission types (e.g., PMAs and 510(k)s) and postmarketing.
This course provides a comprehensive review of medical device regulation in the EU, with emphasis on product lifecycle and an extended examination of the submissions process in the EU. Key sub-topics include clinical assessment of medical devices, Medical-Devices Directive (MDD), conformity assessment pathways and the impact of harmonization efforts on the region.
1. To gain an understanding of US Medical Device Regulation
2. To understand the basics of Clinical Evaluations of Medical Devices
3. To gain an understanding of EU Medical Device Regulatory Structure, including details in Medical Devices Directives (MDD) In Vitro Diagnostic Devices Directive (IVDD) and Active Implantable Medical Devices Directive (AIMDD)
4. Be able to work in a team
5. Be conversant in individual and group presentation and report writing
"

What You'll Learn

The module delves into medical device regulation in the US, with an emphasis on the product lifecycle and an extended examination of the submissions process in the US. Key sub-topics include interactions with the US Food and Drug Administration (FDA), submission types (e.g., PMAs and 510(k)s) and postmarketing. This course provides a comprehensive review of medical device regulation in the EU, with emphasis on product lifecycle and an extended examination of the submissions process in the EU. Key sub-topics include clinical assessment of medical devices, Medical-Devices Directive (MDD), conformity assessment pathways and the impact of harmonization efforts on the region.