SaMD: Common Pitfalls - Classification and Clinical Evidence
Автор: SGS North America
Загружено: 2026-01-10
Просмотров: 26
Описание:
Filmed on October 2, 2025 - Software as a medical device is one of the largest growing fields in the medical device space with a wide range of medical devices from applications on lay user phones, informing them of medical conditions, to advanced artificial intelligence systems which are guiding doctors in diagnosis and prognosis.
Whether you have a software system to log blood pressure and gently nudge user actions, skin lesion monitoring applications, ovulation prediction devices or even mood tracking and alert applications, knowing how to classify these devices and how your claims impact classification and clinical data expectation is crucial to your success.
0:00 Introduction
3:50 Is my software a medical device?
4:32 Am I a medical device?
18:08 What classification is my software?
30:04 Clinical data
36:51 What you need to prove
40:20 What is not a benefit?
46:26 How much evidence is enough?
48:55 What evidence exists?
53:01 Artificial Intelligence
55:45 Q&A
Speakers
Kevin Holochwost - Director, Technical Assessment, SGS North America
Daniel Fisher - Regional Sales Manager - Medical Devices, SGS North America
Learn more: https://www.sgs.com/en/services/softw...
Follow us on LinkedIn: / sgs-certification-solutions
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