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From device cloud connectivity to firmware and cybersecurity, Promenade Software, Inc. has the frameworks and tools to get your product to market faster, with less risk, and without sacrificing safety and quality.
It is crucial that software development does not slow down project timelines. Here at Promenade, we use our robust frameworks that enable us to get right to your project’s unique demands. Our team conceptualizes projects as floating icebergs where we ensure the unseen portions are already fully supported. The top of the iceberg that sits above the water represents the unique requirements to your project. The immense base of the iceberg sitting below the water is the supportive infrastructure.
This blog will dive below the surface, expanding on the frameworks and tools that comprise the essential supportive base that starts your project half done.
Our secure and regulatory compliant CypherMed Cloud services and existing portals empower your device to be “connected” with minimal ramp-up time. It has been built from the ground up to provide easy integration to medical devices.
Cybersecurity and HIPAA compliance are the foremost concerns for CypherMed Cloud. Our system securely transmits and stores patient and device data within our data vault architecture. CypherMed Cloud also fully supports data privacy regulations, including GDPR and CCPA, while enabling authenticated data sharing between patients and care providers. This is especially powerful in the age of at-home care and telemedicine.
With CypherMed Cloud’s device integrations, device health and logs can be collected and used to predict potential failures enabling you to be proactive with scheduling service or preemptive repairs, thus reducing your customer frustrations and downtime.
The Parlay™ system for “self instrumented software” reduces the often overlooked test cycles by as much as 75%. The capabilities of the Parlay system allow engineers to catch issues earlier in the development process because they can literally see AND manipulate in real time.
Simple error injection allows software, systems and quality engineers to create situations within the device software that are difficult or dangerous to replicate through physical manipulation. Utilizing these features during design validation phases leads to more complete error handling and a safer product.
With regulated device industries, the testing process is often a larger effort than the development. With Parlay’s automated testing system based on commonly used languages, the QA process becomes more consistent, reliable, and efficient.
Parlay can be extended into your device manufacturing process as well. The modularity and script-based automation leverages engineering and QA testing to the subsystem, assembly, and unit validation, thus reusing the same processes and metrics created to validate designs during the manufacturing process.
Additionally, Parlay is a powerful diagnostics tool that can be utilized by field service technicians to uncover issues with hardware and software in a malfunctioning device. All with the same intuitive Parlay Workspace interface.
The Parlay framework leads to less variability, less risk, and less overhead, all while achieving increased quality, reliability, and safety of your device.
Promenade provides the full suite of software documentation for a 510(k) or PMA submission. Starting with our carefully prepared templates, we work with our clients to provide the submission documentation, from the plan to requirements, design and implementation, and verification activities at each step. Our controlled processes are IEC 62304 compliant, and we are experts in the Pre- and Post-market Cybersecurity FDA requirements.
Our documentation package includes all relevant checklists and documentation for your project.
• Software Development Plan
• Software Requirements Analysis
• Software Architecture
• Software Unit Testing
• Software Testing
• Software Release
• Software Maintenance
• Software Traceability
• Cybersecurity
• Deliverables
• Software Level of Concern
• Software Development Plan
• Software V&V Plan
• System Hazard Analysis
• Software Hazard Analysis
• Cybersecurity Hazard Analysis
• Software Requirements Specification
• Software Architecture Description
• Software Design Description
• Software Test Procedures
• Software Test Report
• Software Traceability Matrix
• Software Release History and Transfer to Manufacturing
• Cybersecurity Design Features and Controls
• Cybersecurity Penetration Test Report
• Cybersecurity Threat Model
• Software Change Request
• OTS Report
• Software User Interface
