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Promenade Software

Promenade Software provides Software Development and Test Services for medical devices. Medical Device software is our strength and focus - our capabilities span from the device to the entire device ecosystem, including mobile and cloud support. We specialize in advanced software technologies, engineering your system for robustness, security, and safety.

As part of our development services, we offer our pre-validated Parlay Framework for unsurpassed visibility and accessibility into your system. Our Parlay eco-system provides you with quick and efficient device development, with secure, seamless interconnection between devices, mobile, and cloud applications. Our medical device software deliverables are FDA and IEC 62304 compliant, fully documented and ready for regulatory submission. We provide premarket cybersecurity built in, and offer post market cybersecurity services for the life of your device.

Our company is comprised of highly skilled, experienced software engineers with expertise from low level firmware to embedded user applications, mobile apps, and cloud services. We are experts in all aspects of Medical Device Software, including the use of appropriate commercial and open-source technologies, Cybersecurity, Unit and Integration Test, Software Validation, FDA submissions and IEC 62304 compliance.  

Embedded Firmware and Applications 

Promenade Software embedded engineers design software to work closely with the electronics, while providing real-time operating system interfaces, drivers, and controls for your I/O centric subsystems. Using our Parlay-ready embedded framework, complete visibility and control of every low-level element of a system can be accomplished from a PC. Each valve, motor, pump and fan can be controlled from a PC. Temperature, flow rates, pressure... all can be monitored, logged,  and graphed. Higher level application development is streamlined using our pre-developed software frameworks. Our frameworks support QT/QML, Microsoft .Net, or React JS applications for display to an LCD or PC monitor, providing a modern, responsive front-end. Using SQLite for a relational database, and our object relation mapping, your data can be easily organized to a schema, fitting your data storage needs. Our experts in signal processing provide the analytical background needed for your data.

Mobile and Cloud
Embedding our Parlay Connect component, your device connects seamlessly with mobile, and cloud. Your application simply communicates to external software items without complications. Parlay Connect does all the heavy lifting to make it simple. At Promenade, we recognize the significance of mobile and as such we develop mobile apps which either assist in programming, operating or monitoring medical devices and in some cases may actually be the medical device. Our pre-validated robust and secure Parlay Connect system provides the wireless connectivity you need. Whether Bluetooth or WiFi, we can create apps that connect to your device, providing smooth data, control, and status, to and from the device. Using our Parlay base, we can reduce cost in application development. We write once, and deploy to both Android and iOS, each looking like a native application to its OS, with minimal platform specific overhead.

With Parlay Cloud, we simplify data collection and remote diagnostics. We securely connect your system to a remote server so you can provide complete services to your customers. Our BAA with Amazon allows for secure HIPAA data storage with Amazon AWS, or you can choose the provider of your choice. Our RESTful API simplifies access from PC, device, or mobile.

Testing Services
Verification and Validation are key aspects of any medical device development and Promenade Software can assist. We help clients review code, develop test plans, create manual and automated tests, and execute the formal software V&V. We go much further than basic test to ensure your device is ready for market. With our Hardware in the Loop Test System, we can provide test automation, with fault insertion, internal data monitoring and robust component testing. 

We have years of experience making safety critical devices, with FDA and IEC 62304 regulatory requirements, and can help you get through your 510(k), PMA, or CE submission with a robust device.

Cybersecurity and MedISAO
With the many rules and regulations of medical device development and the increased adoption of technology in those devices, cybersecurity has become a new challenge and unfortunately, many devices around the world have been exposed as vulnerable. Medical device vulnerability is a result of modern medical devices becoming more connected. They are connected to local databases, the cloud, and to patients' smart phones. Each one of these connections is a potential attack vector for hackers. The threat is becoming more serious and thus, The Department of Homeland Security revealed last year that it is investigating cybersecurity vulnerabilities in a wide range of medical equipment. Promenade understands the severity of this threat and as such, we practice good cybersecurity hygiene in all our developments. It all begins with having a well thought out cybersecurity plan, from the beginning. It is imperative this occurs as security cannot be bolted on later. We have leveraged industry standard security designs from the cloud and financial industries and incorporated them into prebuilt solutions for medical devices. As technology becomes progressively portable and our devices more linked than ever, the threat of gaps in networks increases as well. Rest assured, by partnering with Promenade Software we have the expertise and solutions to help ensure your device is secure.

Of course, the FDA expects that your device will remain secure and as thus, released the following guidance: Postmarket Management of Cybersecurity in Medical Devices and IEC 29147 Vulnerability Disclosure Requirements. At Promenade Software, we also assist our clients with Managing Postmarket Cybersecurity as it can be a complex endeavor, requiring highly technical staff and comprehensive processes. Our solutions include: monitoring and assessing cybersecurity vulnerabilities, providing a coordinated vulnerability disclosure program, and development of mitigations. Additionally, we created an ISAO called MedISAO which, through membership, can provide medical device manufacturers a comprehensive and proactive management of cybersecurity threats.

At Promenade Software, we have one goal: contribute to our clients’ success. We focus on software each and every day and apply that experience in all of our software development programs. We would welcome the opportunity to discuss how we can help with your success.

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