Loading Events

Virtual Lunch & Learn: FDA Submissions – Best Practices for Early Stage Startups

September 20, 2023 @ 12:00 pm - 1:00 pm

  • This event has passed.

View recording here

Calling all Medical Device startups! Learn about the basics of working with the FDA for Medical Device companies including information on pre-submissions, device classes and classifying your device.

  • Introductions and FDA background
  • Intro to FDA Medical Device classifications
  • Intro to the FDA pre-submissions process
  • Additional and relevant FDA guidance
  • Best practices for first time interactions with the FDA
  • General regulatory best practices for early stage startups

Kristen Mittal, owner of Mittal Consulting, is an accomplished regulatory affairs professional with extensive expertise at Class I, II and III medical device companies, from startups to Fortune 500 companies, with a specialty in electromagnetic and implantable devices. She started Mittal Consulting in the middle of the pandemic after noticing a widespread need in the world of regulatory services for emerging medical device companies and incubator programs. Built by entrepreneurs with entrepreneurs in mind, Mittal Consulting came about to empower small medical device manufacturers with seamless regulatory consulting services- especially with the FDA.

Mridul Mittal, Director of Marketing and Business Development at Mittal Consulting, joined the company recently with a goal to grow and expand the company worldwide. Working at different government organizations, private corporations, consulting firms and engaging with regulatory bodies, he brings a unique perspective in product and spatial marketing. His expertise includes business development, brand creations, digital marketing and account management.

Registration now open!