DIRECTOR OF REGULATORY AFFAIRS
Joined: April 29, 2024
I bring 13 years in medical devices and 30+ FDA 510(k) clearances, leading 510(k), De Novo, and Q-Submission strategy for AI/ML SaMD, IVDs, and surgical tools. As Director of Regulatory Affairs at Innolitics, I lead 510(k), De Novo, and Q-Submission strategy for AI/ML SaMD, IVDs, implants, dental and surgical planning software, reprocessed and electromechanical devices, and surgical tools, and FDA clearance letters for Heartvue.ai, Biotics, Zeto, and USA Therm name me as correspondent. I am an ISO 13485 Lead Auditor and have taught AAMI's 510(k), De Novo, and Lead Auditor courses since 2019.
I am a Medical Device Quality and Regulatory Affairs consultant with a history of working on diverse products within the medical device industry. I have supported 510(k) clearance for over 30 different medical devices, and have helped dozens of companies achieve their Quality and Regulatory goals. My experience spans many different technologies including SaMD (Digital Health, Mobile Apps, AI/ML Contouring, Computer Aided Detection/Diagnosis/Triage), In Vitro Diagnostic Devices, Reprocessed Devices, Electromechanical Devices, Implants, Dental Products, Surgical Planning, Surgical Tools, and more. My technical background is in engineering product development with a degree focused in Biomedical Engineering.
Camping, Watersports, Cooking, Teaching
VideoAI/ML
The talk covers device changes and their regulatory implications using FDA guidance. It focuses on two key documents for deciding when a 510(k) submission is needed for hardware...
Mary Vater
