Course benefit
It is essential to understand and interpret the laws, regulations and the FDA guidance documents for medical devices in order to obtain successful marketing approvals in the USA, and avoid extremely costly delays during this process.

At the end of the Course, participants will leave with a clear understanding of the FDA approval process, associated regulations and recent guidance documents for medical devices essential for successful device development, testing and marketing approvals in the USA. In particular, the participants will have the opportunity to apply their learnings in case studies.  

Course content
The course provides insight to several recently critical guidance documents relating to regulation of medical devices in the US:

• Presubmission Process

• Communication During FDA’s Review of Submissions
• Evaluating Substantial Equivalence for 510(k)s
• De Novo and Special 510(k)s
• Breakthrough Devices Program
• Total Product Lifecycle Advisory Program (TAP)
• Safer Technologies Program (SteP)
• FDA IDE Decisions and Procedures
• Early Feasibility Studies
• Design of Pivotal Clinical Studies
• Recommended Content and Format of Non-clinical Testing
• Product Development Process
• How to deal with the FDA

The course will be conducted in English.

Who should attend
Anyone who has an interest in development of medical devices intended for the US market.   

Instructors
H. Semih Oktay, PhD, Founder and President, CardioMed Device Consultants, LLC

"Semih Oktay is a very knowledgeable lecturer. He chose to go through the legislation with lots of specific examples, adding good humor in between. This approach gave an otherwise complex and tough-to-convey field an easier approachable and digestible angle" 

"The instructor was very experienced in the field and exemplified the content of his presentations based on his own experience, which made the course very interesting/relatable & enjoyable. Very good overall structure to the course, starting with the general overview of the FDA. Excellent delivery throughout the two days"

"The presenter was really knowledgeable about the regulatory opportunities and strategies for submissions"

"Although it was regarding FDA requirements, the speaker did make it very exiting and understandable" 

"Great presentation and informative slides" 

Former Participants