software REGULATORY SERVICES for medical devices

FDA & IEC 62304 Compliant

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), De-Novo, PMA, or MDR/IVDR submission.

FDA logoCDRH logoEU MDR logoGDPR logoHIPAA logo

Design history file

Promenade Software provides the full suite of software documentation necessary for your regulatory submission, as part of our development services. Our controlled processes are fully ISO 13485 certified, and the development activities are FDA and IEC 62304 compliant. We implement and document the cybersecurity, making sure your system is secure and documented per FDA requirements.

Software FDA eStar Templates

Even if you are doing your own development, you can purchase our DHF templates for FDA eStar submission. When you purchase our templates, you also receive 4 hours of expert consultation to guide you along the way.

  • Software Documentation level Evaluation
  • Software Description
  • Software Life Cycle Process Description
  • Software Risk Management Plan
  • Software Hazard Analysis
  • Software Risk Management Report
  • Software Requirements Specification
  • Software Architecture
  • Software Detailed Design
  • Software Verification Plan
  • Software Test Protocols and Test Report
  • Software Traceability Matrix
  • Software Software Version Level History

CyberSecurity Templates

  • Cybersecurity Risk Management Report
  • Cybersecurity Threat Model
  • Cybersecurity Risk Assessment
  • Security Vulnerability Report
  • Cybersecurity Controls
  • Cybersecurity Architecture Views
  • Post-market Cybersecurity Plan
Contact Us
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

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

© 2022 Promenade Software, Inc.