Software has enabled increasingly advanced functionality and interaction in medical devices. Software-driven user interfaces, stand-alone software applications, and mobile medical applications are becoming prevalent within the healthcare ecosystem.
The IEC 62304 standard for Medical Device Software – Software Life Cycle Process has been increasingly recognized by multiple regulatory bodies as a standard by which medical device manufactures can support regulatory compliance claims by implementing the process specified by IEC 62304. The IEC 62304 standard is also now a normative reference for embedded software in medical devices through the Amendment 1 of IEC 60601-1.
The course will also include information on the general requirements for ISO 18562, including analytical technologies and methods. The session will help manufacturers of respiratory devices to understand how to reduce the risk of FDA application rejection and UL's ISO 18562 testing & assessment services include comprehensive support to help manufacturers be prepared for FDA application. We will also introduce GREENGUARD Certification for medical devices, a new program that demonstrates compliance with the ISO standard.
For more information on the event details, visit: http://connect.ul.com/Medical-Device-Software-Demonstrating-Compliance-to-IEC-62304-Seminar-Registration.html