FDA and IEC 62304 Templates

Regulatory Software Submission Materials

Promenade Software regulatory experts have decades of experience preparing the software portion of medical device regulatory submissions. We understand the goals, terminology, and logic of the regulatory bodies and have created a suite of example SOPs and design history file (DHF) documents that can serve as a template for you. Our template materials combine both IEC 62304 and FDA guidelines for class II and III (B and C) software documentation.  They are designed to be clear, and concise, while providing full coverage for the software portion of your submission. Whether you are doing an IDE, 510k, PMA or CE submission, this package will provide the foundation on which you can prepare your software documentation as part of your Quality Management and Risk Management System.

The Promenade DHF Package

Promenade Software offers a package that provides the groundwork for your own software design history file (DHF). The documents provided are examples and templates to kick-start your submission materials. The content should be replaced/filled in with the content that is applicable to your product. 

Planning and Design Control
  • Software Development Plan - Example file to modify to fit your project plan. Includes
    Lifecycle plan, Configuration Management plan, Risk Management plan, Change Control Plan
  • Software Requirements - Baseline document with example software requirements
  • Software LOC, Description, and Architecture 
  • Software Design and Protocol Specifications
Risk Management 
  • Software Hazard Analysis - Software that can contribute to hazards. Includes COTS/Soup and Cybersecurity hazard analysis
  • COTS/ Soup Report - Sample of Identification of COTs used, Anamoly lists
  • Cybersecurity - Design considerations, including list and justification for the controls established, and traceability to risks considered
Software V&V
  • Software V&V Plan
  • Test Cases and Traceability to Requirements
  • Traceability Matrix
  • Test Report
  • Tools Validation Reports - Description of tools used to design, build and test the software, with associated validation evidence
Problem Tracking and Change Control
  • Bug Tracking examples
  • Change Request forms and Traceability of Change
  • Revision History and Unresolved Anamolies

The Promenade SOPs Package

If your have your own software team, you should establish software SOPs as part of your Quality Management System. Use our SOPs as a starting reference for IEC 62304 compliant software development practices.  

About Promenade Software

Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is a Woman-owned Small Business.


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email: info@promenadesoftware.com
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