ComplianceOnline, Online Event
2013-10-22
Why Should You Attend: This webinar will cover the software development process and deliverable requirements of IEC 62304, “Medical Device Software – Software Life Cycle Processes.” It will describe a software development process that integrates the development of needed documentation with development, rather than trying to reverse engineer it. This session will help both software developers and regulatory professionals if they understand what is required for submissions when the medical device contains software. And, if you outsource software development, it will help you manage the work performed by the developer so that you don’t have to reverse engineer the documentation by having someone read the code. Areas Covered in the Webinar: - An overview of IEC 62304 requirements for software development processes
- Software development deliverables that are part of the medical device technical file
- FDA documentation required for premarket submissions for products containing software (IDE, 510k, PMA)
- The alignment of IEC 62304 deliverables with requirements for the content of FDA submissions
- How to make sure that outsourced software developers prepare the needed documentation
- Questions and answers
Free Handouts: - Alignment of IEC 62304 Deliverables with Design Control Requirements
- Alignment of IEC 62304 Deliverables with Requirements for FDA Submissions for Devices Containing Software
- A list of the software development procedures needed by the company and the development vendor
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Invited Speakers:
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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).
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