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Intro to FDA Regulations for Medical Devices, presented by Launch Dayton
April 15 @ 10:00 am - 12:00 pm
Whether you’re an entrepreneur contemplating entering the medical device space for the first time, or a seasoned medical device developer, understanding FDA regulatory compliance requirements is key to your success. In this FREE medtech workshop, Regulatory Mark founder Alison Sathe will provide resources to enable you to take control of your regulatory strategy from concept through design transfer.
Alison will walk you through the structure and function of FDA’s Center for Devices and Radiological Health, and she will share how the regulations pertain to your products. She’ll discuss how device classifications, regulatory pathways, and regulatory and quality compliance requirements pertain to your products and businesses.
You’ll learn how to determine if your product idea is subject to regulation, and if so, how it is classified. You’ll also receive information on regulatory controls for device classifications, premarket pathways including 510(k), De Novo, and PMA, and special programs such as STeP and Breakthrough Devices. Alison will also discuss compliance obligations beyond your premarket submission, including the quality system regulation in accordance with 21 CFR 820.
Ample time will be allotted for Q&A to answer your specific questions.
As a biomedical engineer, Alison began her career working in medical device startups and has specialized in regulatory and quality affairs for over 15 years. Previously an executive team member overseeing Regulatory and Quality Affairs for 100+ employee company with domestic and international sales, Alison has been regulatory lead for multiple product lines from concept and strategy through product release including regulatory submissions and FDA clearance/approval.
Alison founded Regulatory Mark, a co that helps clients of all sizes find the right regulatory strategies for their products and their business. She also founded ClearMark, is an electronic QMS software platform specifically developed for Medical Device designers, developers, manufacturers and entrepreneurs to help you develop products ahead of schedule and within budget.