Medical Device 2020 - Medical Device Software: Verification, Validation & Compliance Webinar

We will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
This webinar is essential for medical device companies interested in submitting software enabled medical devices or software as a medical device to the FDA for 510K approval.
Basic Introduction to 62304
Level of Concern
High Level Risk Management
Medical Device Software User Requirements
Medical Software Device System Requirements
Speaker:
Nancy Knettell, Founder and Principal at Software510, LLC, has over 30 years in combined Mechanical Design, Software Development, and Regulatory experience primarily in the Medical Device industry