Why Should You Attend:
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.
Areas Covered in the Seminar:
Who Will Benefit:
Tim Stein, is the President and CEO of Business Performance Associates, Inc., a consulting firm located in Cupertino, California, that he founded in 1994. Tim’s has provided service to over 95 clients in software development processes, quality systems, and computer system validations. Tim also served as the Director of Software Validation and Quality Assurance at Genomic Health, Inc. (GHI).
For the past couple of years, Tim has focused on IEC 62304 gap analyses and providing leadership in establishing compliant software development processes, including companies that outsourced software development.
He is the author of a hands-on compendium for computer system validation, The Computer System Risk Management and Validation Lifecycle, Paton Press, 2006.
Tim has given 31 public presentations in the past nine years. He is a Fellow of the American Society for Quality and a member of both the Medical Device and Software Quality Divisions. Tim holds a Ph.D. in organizational psychology.
The revised MDD regulations that became effective in March 2010 added an essential requirement that medical device software be developed following state of the art software development processes. As a result, notified bodies are now demanding compliance with IEC 62304, “Medical device software-Software life cycle processes,” as a condition for a CE mark. IEC 62304 also is the only FDA consensus standard for software development.
Medical Device software development is commonly outsourced by both startups and well established companies. Such software must be developed under an IEC 62304 software development process. The problem is that many custom software development companies do not use practices that comply with 62304. The medical device company must work with the software developer to establish processes that are compliant with IEC 62304, and to ensure that the needed deliverables are created and that the deliverables meet the IEC 62304 requirements.
The problem is that many custom software development companies are not trained on IEC 62304 and do not use practices that comply with the standard. This can be true even when the company has experience developing medical device software. Many medical device companies assume that the vendor will develop their software using a compliant process, and they don’t understand IEC 62304 well enough to ensure compliance by the vendor.
Common issues related to ensuring that outsourced software is developed in compliance with IEC 62304 include:
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