Promenade Software
Promenade Software specializes in software development and regulatory compliance services for medical devices, offering a range of solutions including CypherMed Cloud, Parlay framework, and cybersecurity management.
Services
Promenade Software offers a comprehensive range of services tailored to the medical device industry. These include regulatory submissions to FDA and IEC 62304 standards, premarket cybersecurity support, and ongoing cybersecurity management. The company provides software development for medical devices, including firmware, embedded software, mobile apps for iOS and Android, and cloud solutions. Promenade Software also offers automated testing services, software verification and validation, and cybersecurity services compliant with the NIST Cybersecurity Framework and AAMI TIR57.
Products
Promenade Software has developed several notable products for the medical device industry. CypherMed Cloud is a HIPAA, GDPR, and CCPA compliant platform for secure cloud connectivity tailored for medical devices. Parlay, another key product, is a robust framework designed to meet the stringent needs of medical devices. It includes a ready-made user interface to control and monitor device subsystems and offers support for commercial customers, including licenses.
Regulatory Compliance
Regulatory compliance is a cornerstone of Promenade Software's offerings. The company provides comprehensive services to meet FDA and IEC 62304 standards. They utilize a library of checklists and over 20 templates for regulatory documentation, including the 510(k) submission process. The company's adherence to HIPAA, GDPR, and CCPA standards ensures that their cloud platform, CypherMed Cloud, meets stringent regulatory requirements.
Cybersecurity Services
Promenade Software offers extensive cybersecurity services designed to protect medical devices throughout their lifecycle. This includes the development of a Cybersecurity Bill of Materials (CBOM) to identify and address vulnerabilities, a comprehensive cybersecurity management plan for ongoing vulnerability monitoring and incident response, and premarket cybersecurity support. Their services are compliant with the NIST Cybersecurity Framework and AAMI TIR57.
Software Development and Engineering
All engineering work at Promenade Software is conducted in Southern California, with no off-shoring. The company specializes in custom software development for medical devices, producing embedded software, mobile applications, and web applications. Their engineering capabilities also extend to automated testing, including Hardware in the Loop (HiL) and UI testing. Their mobile app development services offer BLE and WiFi connectivity to enhance functionality and usability.