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Next Generation Tactics for 510(k) Submissions

  • CIC Cambridge: 5th Floor, Havana Room 1 Broadway Cambridge, MA, 02142 United States (map)


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.

About Right Submission:

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.

About Juan Carlos Serna:

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.

Earlier Event: March 9
Meditation (Cambridge)
Later Event: March 9
Weekly Food Demos at Branchfood