Software Validation 2020 - What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC

If your company need to file for 510K approval for Software as a Medical Device (SaMD) or software enabled medical Devices to the FDA for, this webinar is for you. After waiting for seven or more months
Medical device companies need to join this webinar to ensure that they know exactly what documentation needs to be prepared and submitted. They will also understand how to warrant that all documentation is prepared appropriately
Lecture 1
Why is having an IEC62304 Compliant Software Quality System important to both developing your software for 510K approval and how you can be putting your company at risk post-approval if you do not have a compliant system in place
Speaker:
José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry