Medical Device 2021 - IEC 62304 and Demystifying Software Validation using the Principles of LDLC - Medical Device classes online Training

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 to find you’re device approval has been denied because the software section of the submittal is inadequate and not compliant
This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software Life-cycle and software validation protocols. Rather than be overwhelmed by continuing to apply paper document methods and approaches to software configuration and validation
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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 specializing in manufacturing,