Promenade Software

Promenade Software is a company dedicated to providing software development and regulatory compliance services for medical devices and other safety-critical applications. The company ensures adherence to FDA and IEC 62304 standards and offers a range of services including software regulatory submissions, premarket cybersecurity support, and lifecycle cybersecurity services. All engineering work is conducted in Southern California, with no off-shoring. Promenade Software developed CypherMed Cloud, a HIPAA, GDPR, and CCPA compliant platform, in response to the growing need for secure cloud connectivity in medical devices. The company also offers mobile app development for iOS and Android, including BLE and WiFi connectivity, and provides a Cybersecurity Bill of Materials (CBOM) service to identify and address vulnerabilities. Their Parlay framework is designed to meet the stringent needs of medical devices, and they utilize a library of checklists and templates for regulatory documentation, including 510(k) submissions. Promenade Software’s suite of capabilities extends to embedded software, mobile applications, web applications, and cloud solutions, with additional services in automated testing, software verification and validation, and custom software development for medical devices. They provide a comprehensive cybersecurity management plan, including vulnerability monitoring and incident response, and offer companion apps to enhance the functionality and usability of medical devices. Their services are compliant with the NIST Cybersecurity Framework and AAMI TIR57, ensuring robust cybersecurity measures are in place.