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Getting FDA Clearance/Approval for Medical DevicesWhat, When and How?
The thriving medical device industry has brought with it a bombardment of regulations and requirements which continue to increase as the industry itself develops. The main challenge for industry is no longer to merely identify the applicable regulations but to identify the means by which to apply the applicable regulatory framework in order to successfully gain market entry and remain...Continue reading
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Issues to be covered
- Legislation governing development, manufacture and commercial distribution of medical devices
- Classification of medical devices
- Requirements for pre-clinical and clinical testing
- Processes for communicating with FDA
- Submissions for obtaining marketing clearance\approval
- FDA enforcement methods
- Specific compliance issues related to medical devices
Who should attend
This course is intended for individuals with responsibility for FDA regulatory affairs in medical device companies that are new to the profession or are interested in expanding their knowledge
Benefits to the Participants
Participants in this course will:
- Get an overview of FDA regulatory framework for bringing a new medical device to the market
- Gain knowledge of the requirements and regulatory processes
- Study from experience of others by learning and discussing case studies
- Have an opportunity to share their regulatory challenges and experiences with colleagues
About The Lecturer
