34% of 510(k) submissions are delayed due to administrative errors.
During this interactive workshop we will explore:
- An overview of FDA guidance currently available
- Root causes of delays
- The anatomy of a 510(k) submission
- Case studies for working smarter and faster
The discussion will be facilitated by Juan Carlos Serna, President and co-founder of Right Submission. The event will be held at the Cambridge Innovation Center and will be co-sponsored by Mass Medic.
Right Submission changes the way biotechnology companies handle regulatory applications by streamlining the submission process and ensuring accuracy and completeness, thereby achieving FDA approval faster.
Juan Carlos Serna has over 16 years of experience in leading FDA-regulated industries with preclinical and clinical biotechnology research, clinical trials, regulatory affairs, and quality assurance. He offers extensive best-practices experience in medical device regulations, IND/NDA regulatory submissions, Good Clinical Practices (GCP), Quality System Regulations (QSR), Good Clinical Data Management Practices (GCDMP), Good Laboratory Practices (GLP), and executing regulatory submissions including many 510(k) submissions across a broad span of areas.
Attendance in person is encouraged. After registering, you will receive a confirmation email containing information about joining the webinar if you are unable to join us in person.