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  • Reduce Software Documentation Time and Cost for the MDD
    Technical File and FDA Submission

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Nov 21, 2013 10:00 AM
  • End Time:
  • Thursday - Nov 21, 2013 11:15 AM
  • Location:
  • Online
  • This training on medical device software documentation requirements will review the types of documents that are required by IEC 62304 and the FDA for 510k and PMA submissions. It will also describe the content requirements for several key documents. You will learn how to reduce time and money spent in documenting software.

    Why Should You Attend:
    It will help both software developers and regulatory professionals if each group understood what is required for submissions when a medical device contains software. While Regulatory Affairs bears final responsibility for the submission and technical file, software development must provide the software related content. The entire company shares the same goal: a safe and effective product with market clearance from the regulators. This goal needs to be achieved through an effective and efficient process. If you outsource software development, it will help you manage the work performed by the developer so that you don’t have to have someone read the code to figure out and document the requirements and design. Most outsource software developers, even many of those with a track record for developing medical device software, think that it is the responsibility of the medical device company to prepare the software documentation.
    This webinar will review what documentation is required for the submissions and the technical file. The instructor will then review the content required for the software development plan, software requirements, the detailed design, test protocols and problem reports. Emphasis will be placed on the aspects of the documentation that is missed most frequently. Recommendations will be made for how to minimize the documentation workload by the creation of procedures and templates.

    Areas Covered in the Webinar:
    -The IEC 62304 documentation requirements
    -Software development deliverables that are part of the medical device technical file
    -Documentation required for FDA premarket submissions for products containing software (510k, PMA)
    -The alignment of IEC 62304 deliverables with requirements for the content of FDA submissions
    -Content requirements for the software development plan, software requirements, the detailed design, test protocols and problem reports
    -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 SoftwareA list of the software development procedures needed by the company and the development vendor

    Who Will Benefit:
    -Software engineers who need to understand what the regulatory requirements are for the development of medical device software
    -Regulatory affairs professionals who need to understand the documents that are required for technical files and FDA submissions
    -Those who write software documentation
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