Lunch & Learn: A Regulatory Primer for MedTech Startups

Your Regulatory Strategy Is Key

For medtech startups, regulatory approval is on the critical path to getting a product to market, and funding for your company. We are fortunate to have someone with that experience in Daybreak Labs Med ech Regulatory Advisor, Vrushali Tembe, Vice President, Global Regulatory Affairs, P+F Products + Features GmbH. As our newest Daybreak Labs advisor, Vrushali will give an overview of critical steps in the regulatory pathway for early stage medtech companies companies followed by a Q&A session.

Questions in advance? Email us at info@daybreaklabs.io.

About Vrushali Tembe, Daybreak Labs MedTech Regulatory Advisor

Vrushali Tembe has deep experience in global regulatory strategy and submissions bringing innovative medical devices into new markets. She is responsible for worldwide licensing of class III, II, I medical devices with diverse experience in structural heart cardiovascular replacement/repair devices, diabetes care and SaMD. In addition, she has been integrally involved in new product development, clinical-regulatory strategy, Q-Sub, US 510(k), IDE/PMA, EU MDD/MDR and global regulations.

Vrushali brings a strategic mindset with a business focus on meeting stakeholder expectations (clinicians, patients, regulators, and payors). She has a proven track record in people and organizational development. As an experienced business leader and Board member, she drives strategic business transformation. Vrushali is passionate about harnessing the power of science and building collaborative relationships across the healthcare continuum.