US FDA Submission Process for Medical Devices

When:  Feb 3, 2020 from 5:00 PM to 6:15 PM (MT)
Associated with  ACRP Front Range Chapter

To purchase your contact hour, please click here.

Regulatory submissions are a result of teamwork, often occurring over many years. Each person involved in the testing, organization, or clinical studies is integral to the success of the submission.

This session will take a step by step approach to walk attendees though what is required in the 510(k) and PMA submission process; and how you can best support the process.

In order to commercialize, additional FDA establishment registration and device listings are required; these registration/listings help the FDA plan facility inspections

Participants of this session will get a broad appreciation of the submission process and some best practices to support your team in the regulatory submission process.

Speaker:
Angela Mallery, EdD
Principal Product Development Strategist
NAMSA


*THIS EVENT IS A REPLAY OF A PRESENTATION FROM THE 2019 GLOBAL CONFERENCE AND  IS REMOTE ACCESS ONLY.


Please note: This is a replay of an ACRP2019 Conference Session.

Location

Dial-in Instructions:
Please RSVP to the contact person listed in order to receive the dial-in instructions for this webinar. THIS EVENT IS REMOTE ACCESS ONLY