Software Validation Procedure (SYS-044)

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The Software Development and Validation procedure aims to define the documentation requirements and the process for product software development and validation within the Company’s quality management system. The procedure is appropriate for companies developing software as a medical device (SaMD) and software in a medical device (SiMD).

Software Development Procedure Software Validation Procedure (SYS 044)
SYS-044 - Software Development and Validation Procedure
SYS-044 Software Development and Validation Procedure; This procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.3.6 and 7.3.7 for design verification and design validation of medical device products. This procedure is also intended to meet the requirements of IEC 62304, ed. 1.1 and 21 CFR 820.30(a)(2)(i) and (g). Finally, the procedure is updated to reflect the requirements of the 2023 FDA guidance for pre-market submission content.
Price: $299.00

Does the software validation procedure meet the most recent requirements?

This procedure is intended to meet the requirements of ISO 13485:2016, Clause 7.3.6 and 7.3.7 for design verification and design validation of medical device products. This procedure is also intended to meet the requirements of IEC 62304, ed. 1.1 and 21 CFR 820.30(a)(2)(i) and (g). The procedure content has also been updated to comply with the 2023 FDA guidance for software documentation in pre-market submissions. The 2023 guidance requires that companies document the software risk documentation level as basic or enhanced. TMP-019 can be used to document this and attached to the eSTAR in the section shown in the screen capture below:

Software Documentation Level 1024x549 Software Validation Procedure (SYS 044)

The FDA eSTAR also requires that companies attach nine different types of software validation documentation, as shown in the screen capture below:

Software Documentation 1024x470 Software Validation Procedure (SYS 044)

One of the less obvious changes in the requirements is a requirement for submission of a software risk management file. instead of providing only a software hazard analysis:

  1. A risk management plan,
  2. Risk assessment (hazard analysis), and
  3. Risk management report.

Software Risk Management File Software Validation Procedure (SYS 044)

Does this software validation procedure include quality system software?

This procedure does not apply to the requirement for quality system software validation in ISO 13485:2016, Clause 4.1.6, validation of software for automated equipment in Clause 6.3 and 7.5.6, or validation of software used for monitoring and measuring calibrated equipment and devices in Clause 7.6. Those requirements are covered in SYS-014 Process Validation procedure, and the applicable technical standard is ISO 80002-2:2017.

This is the primary document meeting the applicable regulatory requirements for software development and validation as defined in the Quality System Manual (POL-001).

What is included with the purchase of this procedure?

The following is a list of documents included:

  • SYS-044 A, Software Development and Validation
  • TMP-009 Software Development Plan Template
  • TMP-010 Software Requirements Specification Template
  • TMP-011 Software Traceability Matrix Template
  • TMP-012 Software Architecture Specification Template
  • TMP-013 Software Design Specification Template
  • TMP-014 Software Revision Level History Template
  • TMP-017 Software Development Environment Description Template
  • TMP-018 Software Description Template
  • TMP-019 Documentation Level Evaluation Template
  • TMP-020 Software Risk Management Plan (RMP)
  • TMP-025 Verification Protocol Template
  • TMP-026 Verification Report Template

In addition to the procedures and templates, we have also created a zip folder with all four of the FDA guidance documents for software submissions:

  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
  • Guidance for Industry, FDA Reviewers, and Compliance on Off-The-Shelf Software Use in Medical Devices
  • Guidance for Industry and Food and Drug Administration Staff Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
  • Guidance for Industry, FDA Reviewers, and Compliance on Postmarket Management of Cybersecurity in Medical Devices

You also need to purchase a copy of IEC 62304:2006 from your favorite standards issuer.IEC 62304 2006 from evs.ee website 300x196 Software Validation Procedure (SYS 044)Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures, click here.

About the Author

Mary Head Shot 150x150 Software Validation Procedure (SYS 044)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 as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.

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