The FDA’s Action Plan for AI-ML-Based Software As A Medical Device

by | Mar 1, 2021 | Uncategorized

In this webinar hosted from EMMA International’s Software Engineer, Govind Yatnalkar, he focuses on the recently released FDA’s action plan for regulating AI/ML-based software as a medical device (SaMD). He then dives into the five major action items provided in the action plan along with examples that define the actual regulation strategies for AI/ML-based SaMDs.

Get the Action Plan for AI-ML-based Software As A Medical Device Webinar

Fill out the form below, and the webinar will get sent directly to your inbox.
Govind Yatnalkar

Govind Yatnalkar

More Resources

Pattern Recognition as a Quality Superpower

Pattern Recognition as a Quality Superpower

There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.
Record Control for a Regulated World

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
EU MDR SSCP’s: The Importance of Readability

EU MDR SSCP’s: The Importance of Readability

Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.

Ready to learn more about working with us?

Pin It on Pinterest

Share This