software REGULATORY SERVICES

Promenade Software provides software regulatory services for Medical Devices. We have years of expertise in FDA and IEC 62304 regulatory submissions, and can help you get through your 510(k), PMA, or CE submission.

Design history file (DHF)

Promenade Software provides the full suite of software documentation necessary for your IDE, 510(k), PMA, CE  submission, as part of our development services. Our controlled processes are fully FDA 21CFR Part 820, ISO 13485 and IEC 62304 compliant.

If you are doing your own development, our experts can guide you on the software portions of the design history file (DHF), or if you have your DHF, we provide audit services, helping you avoid a costly denial.

Below are some of services provided

design control

  • Software Development Plan - Lifecycle plan, including Configuration Management Plan, Risk Management Plan, Documentation Plan
  • Software Requirements - We will help you define and write complete, unambiguous, and verifiable requirements
  • Software Architecture and Design

risk management

  • Software Hazard analysis and traceability to the associated mitigations
  • COTS Reporting - Documentation and Hazard Analysis and Mitigations
  • Cybersecurity - Cybersecurity Design Controls, Threat Modeling, Cyber Hazard Analysis, Penetration Testing, CBOM generation and post-market Vulnerability Monitoring

CYBERSECURITY

  • Cybersecurity - Cybersecurity Design Controls
  • Cybersecurity Risk Management - Threat Modeling, Cyber Hazard Analysis, Penetration Testing
  • CBOM generation and post-market Vulnerability Monitoring

SOFTWARE TEST AND V&V

Promenade test services are specially tailored to your device. We develop innovative test strategies to make sure all aspects are covered. We start with the Risk Analysis to understand the the safety critical aspects of your devices to prioritize your testing. From unit test, integration test to system-level test, we make sure your device is ready for market. We engineer the test creating automated scripts to verify the performance, functionality, and user experience under good and bad conditions.


Our testing exercises the system software in ways not accessible by a user. With Parlay™ and DigiWorx (Promenade's Hardware in the Loop Test system) we can provide you with test automation, including fault insertion, internal data monitoring and robust component testing.
Our testing fully characterizes your system under normal and stress use to ensure your system is able to gracefully handle unexpected situations.

  • Software V&V Plan
  • Test Cases
  • Test Report
  • Traceability from System Requirements to Software Requirements, Hazards, Design and Verification
  • Release history and unresolved anomalies


Whether you are doing development with us, or just need help with your submission, let our software regulatory expertise help you navigate through the regulatory process.

16 Technology Drive, Suite 100
Irvine, CA. 92618, U.S.A.
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PROMENADE SOFTWARE

Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is ISO 13485 and CyberMed • Cloud is SOC2 Type II certified.

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