Promenade Software

Promenade Software specializes in software development for Class II and Class III medical devices, focusing on the complete software lifecycle from embedded firmware to cloud platforms. Founded in 2013 and based in Irvine, California, the company maintains ISO 13485 certification and SOC 2 Type II compliance for its cloud systems.

The company's core offerings include three main areas: embedded development through their proprietary Parlay framework, mobile applications for Software as a Medical Device (SaMD) and BLE-connected devices, and cloud solutions via their CypherMed Cloud platform. All development work includes regulatory documentation for FDA 510(k) submissions and IEC 62304 compliance. Promenade maintains an entirely US-based engineering team with degrees in computer science, computer engineering, or electrical engineering.

The company has worked with major medical device manufacturers including Edwards Lifesciences, Teleflex, and RxSight, as well as emerging digital health companies. Their client portfolio spans diagnostics, therapeutic devices, monitoring systems, and connected medical devices requiring secure cloud connectivity and regulatory approval.

Choose Promenade Software when FDA regulatory compliance and quality documentation are non-negotiable requirements. Their pre-validated frameworks and template libraries can significantly reduce time-to-market for Class II and III devices compared to building regulatory infrastructure from scratch.

Expect a collaborative engagement model with engineers who understand both the technical and regulatory aspects of medical device development. The company's track record with major device manufacturers and their Quality Management System certification provide confidence for risk-averse organizations navigating FDA submissions.

Promenade Software operates exclusively in the medical device sector, with 100% of their business focused on software for regulated healthcare devices. Their expertise spans diagnostic devices, therapeutic equipment, patient monitoring systems, and connected medical devices requiring cloud infrastructure. The company's ISO 13485 certification and FDA regulatory knowledge demonstrate deep commitment to healthcare quality standards.

Their client base includes cardiovascular, respiratory, diabetes management, diagnostic testing, and surgical device manufacturers. The company participates in FDA working groups and maintains current expertise in evolving cybersecurity requirements for networked medical devices.

Medical device companies developing connected devices that require FDA clearance, particularly those in Class II or III categories. Organizations that value regulatory expertise and comprehensive documentation as much as technical development, and those willing to invest in quality processes that withstand FDA scrutiny. Suitable for both established device manufacturers updating legacy products and startups building novel medical devices from the ground up.