SaMD: Common Pitfalls - Classification and Clinical Evidence

Software as a medical device is one of the fastest-growing fields in the medical device space, with a wide range of medical devices from applications on lay users’ phones informing them of medical conditions to advanced artificial intelligence systems 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 expectations is crucial to your success.

Objective

• Be able to properly classify SaMD devices.
• Understand what constitutes clinical evidence for SaMD.
• Understand the ramifications of declaration or presence of artificial intelligence and artificial intelligence-trained devices.

Agenda

• Is my software covered by the MDR?
• Claims, intended use, and intended purpose are everything.
• What class is my software?
• Understand how to apply MDR rules to an SaMD device.
• Examples of how to consider application of MDCG 2019-11, Guidance on Qualification and Classification of Software.
• What are SGS and NB expectations for classification review? How to document consideration of all rules.

Clinical Evidence for SaMD:

• How do your claims, IFU, website, and brochures all come together to guide a notified body in how we look for clinical evidence in support of your device? Everything here is applicable to both MDR and UKCA.
• Where does an NB look for claims?
• What is a clinical claim?
• What is a benefit?
• What do you need to prove?
• Why is equivalence harder for SaMD?
• Do I need clinical evidence?
• Why you are probably not Article 61(10).
• What constitutes clinical evidence?
• What kind of evidence is more often available to SaMD?
• What is the relationship to the PMCF plan?

Bonus:

• Understanding the ramifications of declaring the presence of artificial intelligence.

Target Audience: Regulatory affairs experts and client representatives responsible for the compilation of clinical evidence in accordance with Annex 14 and Article 61, and all personnel responsible for the generation of technical documentation packages.

Language: English

Cost: No Charge

Can’t make the live session? Register now and receive a complimentary recording after the live event.

Speakers:

Kevin Holochwost

Director, Technical Assessment, SGS North America

Kevin Holochwost has worked in the regulatory industry as a member of notified bodies for a decade and has worked in the medical device field designing software and hardware systems for twenty years. Before working in medical devices, he worked as a physicist and statistician.

Daniel Fisher

Regional Sales Manager, Medical Devices, SGS North America

Daniel Fisher is the Regional Sales Manager for Medical Devices in the Western U.S. He is an Electrical Engineer and has been with SGS for four years. In his tenure at SGS, Daniel has worked closely with hundreds of MD and IVD manufacturers to achieve Quality and Regulatory Certifications.

For further information, please contact:

Dominic James
Marketing Assistant
t: +1-862-339-6737