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

This webinar was presented on Thursday, October 10, 2019, by Mary Vater. If you were unable to attend the live session, we recorded the session and a download link for this 510k software documentation webinar will be sent by email to you if you fill out the form below. 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 12 documents that are typically included in this section of the submission for software with a moderate level of concern. This webinar is also applicable to software as a medical device (SaMD).

510(k) Software Documentation Webinar

• 1. Level of Concern (LOC) – Level of Concern refers to an estimate of the severity of injury that a device could permit or inflict, either directly or indirectly, on a patient or operator as a result of device failures, design flaws, or simply by virtue of employing the device for its intended use.
  2. Software Description – A summary overview of the features and software operating environment.
  3. Device Hazard Analysis – Tabular description of identified hardware and software hazards, including severity assessment and mitigations.
  4. Software Requirement Specification (SRS) – This documents the requirements of the software with regard to hardware requirements, programming language requirements, interface requirements, software performance, and functional requirements.
  5. Architecture Design Chart – Detailed depiction of functional units and software modules. May include state diagrams as well as flow charts.
  6. Software Design Specification (SDS) – The SDS describes how the requirements in the SRS are implemented. The information presented in the SDS should be sufficient to ensure that the work performed by the software engineers who created the Software Device was clear and unambiguous, with minimal ad hoc design decisions. The SDS may contain references to other documents, such as detailed software specifications.
  7. Traceability Analysis – Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.
  8. Software Development Environment Description – Summary of software life cycle development plan, including a summary of the configuration management and maintenance configuration activities.
  9. Verification and Validation Documentation – Description of software verification and validation activities at the unit, integration, and system level. System-level test protocol, including pass/fail criteria and tests results.
  10. Revision Level History – Revision history log, including release version number and date.
  11. Unresolved Anomalies (Bugs or Defects) – List of remaining software anomalies annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors.
  12. Cybersecurity – The process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.

Our procedure for software validation (SYS-044) is available:

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Additional Resources for 510k submissions

If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.

About the Author

Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices, software as a medical device (SaMD), and software utilizing artificial intelligence (AI). She also has experience with CE Marking and Canadian Licensing applications. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.