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, EdDPrincipal Product Development StrategistNAMSA
*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.
With more than 20,000 members, the Association of Clinical Research Professionals (ACRP) is the only non-profit solely dedicated to representing, supporting, and advocating for clinical research professionals. ACRP supports individuals and life science organizations globally by providing community, education, and credentialing programs. Founded in 1976, ACRP is a registered 501(c)(3) charitable organization whose mission is to promote excellence in clinical research and whose vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world.
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