This 510(k) training will provide an understanding of how to get a medical device requiring a 510(k) submission to market as quickly as possible. This presentation will describe the 510(k) submission process and the contents required by the FDA for a successful submission. The webinar will provide an understanding of the common pitfalls, additional information request, and potential preventive measures. Moreover, the presentation will describe the type of interaction a manufacturer can pursue while awaiting for FDA approval.
Duration: 60 Minutes
Group of 3 to 5
Group of 6 to 10 + DVD-USB
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.