There are several documents needed in your Software Design History File (DHF) to describe your software controls and risk management.  The list of requirements from the FDA and IEC 62304 can be daunting. Below are some of the documents required that we can help you with:

• Level of Concern (LOC)
• Software Development Plan (SDP)
• Software Requirements Specification (SRS)
• Software Hazard Analysis
• Cybersecurity Threat Model
• Cybersecurity Hazard Analysis
• Software Architecture
• Software Detailed Design
• Cybersecurity Design Features
• Software V&V Plan
• Software Verification Procedures
• Cybersecurity Test and Vulnerability Scan Report
• Software Verification Final Report
• Revision History and Unresolved Anomalies

At Promenade Software, this is our bread and butter. We have checklists and templates for each part of the development lifecycle making sure your submission is FDA and IEC 62304 compliant. With our consulting services, you can choose the level of help you need. From simply purchasing the checklists and templates, to us performing a gap analysis of your documentation and providing consultation, to help writing the documents - we can assist you, and make sure your submission goes smoothly.