DIRECTOR OF REGULATORY AFFAIRS
Joined: April 29, 2024
With 13 years in medical devices and more than 30 FDA 510(k) clearances, I have worked across implants, IVDs, surgical planning, instrumentation, wearables, and AI/ML SaMD. Notable SaMD clearances include K260811 Heartvue.Proton, K250959 BioticsAI, K250416 GBrain MRI, K230575 Limbus Contour, K220205 Ricoh 3D Anatomic Models, K212622 Zyter RPM, and K202151 Smart SPACE Shoulder System. As Director of Regulatory Affairs at Innolitics, I lead 510(k), De Novo, and Q-Submission strategy. I am also an ISO 13485 Lead Auditor and have developed and taught AAMI's courses on 510(k)s, De Novo, post-market surveillance, and lead auditing 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.
My husband and I maintain full hands and hearts with 3 little kids (ages 1, 3, and 4). We love spending time outdoors camping and boating. I love to cook and bake. We also enjoy traveling and finding our way to beach or the mountains when Kansas is looking a little flat.
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
