510k software documentation webinar

This 510k software documentation webinar defines the software documentation requirements to be included in section 16 of a 510k submission for a medical device with a moderate level of concern.

Screenshot 2015 12 13 at 8.56.17 AM 300x222 510k software documentation webinar

A download link for this 510k software documentation webinar will be sent by email to you if you fill out the form to the right. For 510k submissions to the US FDA, section 16 of the 510k submission describes the software verification and validation (V&V) activities that have been conducted to ensure the software is safe and effective. There are 11 documents that are typically included in this section of the submission for software with a moderate level of concern.

510k software documentation webinar content

    1. Level of Concern
    2. Software Description
    3. Device Hazard Analysis
    4. Software Requirement Specification (SRS)
    5. Architecture Design Chart
    6. Software Design Specification (SDS)
    7. Traceability Analysis
    8. Software Development Environment Description
    9. Verification and Validation Documentation
    10. Revision Level History
    11. Unresolved Anomalies (Bugs or Defects)

Nancy Knettell’s Procedures and Forms for Software Validation will be Available Soon on Our Website


SOPS 510k software documentation webinar

About Your Instructor

nancydone 150x150 510k software documentation webinarNancy Knettell is a graduate of UMass Lowell in information and software development technology. Nancy also has a master’s in management science from Lesley University. She has a decade of experience in the medical device industry and more than 20 years of experience in software development. Nancy was a senior manager at several companies—including Director of Program Management at UTC/Pratt & Whitney/Altair Avionics Corporation. Her software life-cycle management expertise covers all aspects of developing, training, implementing and maintaining compliance with IEC 62304.


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