Are you developing a medical device with software or firmware? If you plan on submitting your device to the FDA, there are specific regulatory requirements that must be met to ensure acceptance. In this webinar, you will learn the best practices for software and firmware development in a regulated field like medical devices. In the medical device industry, ISO 13485 defines requirements for a quality management system that demonstrates the ability to create medical devices that meet customer and regulatory requirements. Because of the inherent complexity of software systems, software development has become more tightly controlled than hardware in regulatory environments. Thus, standards have emerged to guide this process specifically for software. Under ISO 13485, medical devices containing software or firmware must be developed according to IEC 62304.
The processes put forth by IEC 62304 are established best practices in the software industry, most of which can be followed for both medical and non-medical projects. The activities described in the standard fit neatly into many phase-based product development approaches. This talk will focus on a phase-based product development approach that meets these standards through planning, risk management, architecture, detailed design, and verification.
This Lunch & Learn is a virtual event, using Zoom Meeting. After registration, you will receive emailed instructions for joining the meeting. Grab your lunch in the comfort of your home or office, and join us online!
Please note: This program will be recorded.
Speakers: Dorota Shortell and Katie Elliott from Simplexity.
Thank you to Simplexity for sponsoring this event!