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This is a bare basics overview of how medical devices are regulated in the European Union (EU). You will learn how the EU government creates laws and regulations that control medical device approvals there.
The course covers three main areas:
1) Governmental structure of the EU
2) The EU Directives that deal with medical devices
3) The structure of a Tech File/Design Dossier which is submitted for a device.
The course is intended for those with no knowledge of device regulation in the EU. After taking this course, you will understand where to go next with your EU device project, from a regulatory standpoint, and you will know how to gain additional learning for your desired device approval.
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|Section 1: European Medical Device Regulatory Basics|
This lecture describes the course and who should take it. By the end, you will understand if you can benefit from the information.
Description of some basic regulatory terms and concepts in the EU:
* Competent Authority
* Notified Body
* Authorized Representative
* CE Mark
Gain an understanding of the overall structure of the EU Government and how it proposes and adopts legislation. These rules, known as Directives, are then fulfilled by the member states.
Overview of the three different medical device directives:
93/42/EEC - Medical Device Directive (MDD)
98/79/EC - In vitro Diagnostic Directive (IVDD)
90/385/EEC - Active Implantable Medical Device Directive (AIMDD)
NOTE: Check back with this lecture in late 2015 to see changes for new EU directives to issue.
Description of content that goes into a Tech File and a Design Dossier. Outlines the structure of the files and how they are used to gain approval (CE Marking) for a device in the EU.
Currently, I am Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology. For over 10 years, I have worked in various roles developing medical devices and have touched perhaps hundreds of them in varying capacities from concept to launch.
As someone that loves to give back and feels obligated to teach those that are coming after me in the medical device industry, I have always said that it is important to excel in at least two things. Every day I try to be an example to my coworkers and students by using my experience in research and business to bridge the gap between the two. This usually involves conversations from all perspectives covering project management, medical device product development, marketing, training, and research planning. Being able to explain tough concepts to audiences without background in a subject has been my forte, and I have used it in numerous device companies, sales training classes, CME, and Grand Rounds presentations around the world. Going the other way, I have conveyed crucial business strategies to motivate product development and research professionals both in industry and academia. While my formal training is in general business and Biomedical Engineering with specific interest in bone tissue engineering and biomaterials, I see myself as a translator. The languages of business and science are not often mutually understood, and I act as the intermediary.