SaMD (Software as a Medical Device) is one of the fastest growing types of Medical Devices in the world. This is creating a unique situation where traditional software companies are now becoming Medical Device Manufactures (MDMs) and traditional MDMs are developing more and more software.

This training is designed to give attendees a crash course in software only medical devices. Learn and understand what software qualifies as SaMD and how it can be unique from commercial software as well as from traditional medical devices. The webinar will provide a high-level review of the Quality Management System Regulations (QMSR) from a software lens. Learn what portions of the QMSR apply to SaMD and what that means for your company.

This training will also provide an overview of all the software activities required by ANSI/AAMI/IEC 62304:2006/A1:2016 and the FDA’s General Principles of Software Validation (GPSV). This will include Safety & Security Risk Management, Software Development & Implementation, Software Verification, Design Validation, Software Releases & Maintenance, and other various required activities for SaMD.

Lastly, this training will guide you from both angles to support you in becoming a SaMD expert. Register now and accelerate your journey to better understand the regulations, development, implementation, and validation of SaMD

Over the course of (6) hours, the attendee will:

• Understand what SaMD is and how it is unique
• Understand how to utilize industry standard software development practices to meet the compliance requirements of medical device software
• Understand how Medical Device Regulations specifically apply to software only devices

Anyone wanting to better understand medical device software regulations or software only medical devices.

• Software Engineers and Managers
• Other R&D Engineers and Managers
• Quality Engineers and Managers
• Regulatory Specialists