Medical Devices 2011 - Outsourcing Medical Device Software Development with Compliance to IEC 62304

This 3-hr webinar will show how a medical device company can work with the software developer to establish IEC 62304 compliant processes, and ensure that the software developed meets IEC 62304 requirements.

In order for a medical device company to meet the requirements for a CE mark, the software must be developed in a manner that meets the requirements of IEC 62304, “Medical device software-Software life cycle processes.”

But. most software development vendors don’t understand IEC 62304 well enough to ensure compliance. As a result, the software is developed in a manner that is not compliant, and the documentation required by IEC 62304, and needed for the FDA submissions, is not created by the developer.

In this webinar, common issues related to ensuring that outsourced software is developed in compliance with IEC 62304 will be addressed. The training will also include an overview of IEC 62304 because the first step to managing a vendor for compliance is to understand the standard.