medical device
Software development services

Reduce the Risk, Cost, and Time It Takes to Get Your Medical Device to Market

We have the experience and infrastructure to efficiently get your medical device to market


Your trusted source for medical device software from embedded to cloud
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Embedded
Development

From firmware to embedded applications, we have the frameworks and know-how to provide complete and robust solutions for class II and III devices.
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Mobile
Applications

Whether SaMD or BLE connected, we have the experience, and regulatory expertise for iOS and Android for medical devices.
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Web
Applications

Utilizing our certified CypherMed Cloud solution, we can quickly get an efficient, secure, and effective cloud solution for your device.
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All of the above engineering development services include regulatory compliance to FDA and IEC 62304 standards

Streamline your technology innovation with a partner committed to making medical device development more efficient and cost effective

We have invested in the creation of verified frameworks and infrastructure required to simplify productization of medical devices

Medical Device Firmware and Software

Parlay is designed for the stringent needs of medical devices. The self-instrumenting codebase and libraries provide unmatched visibility and access to the system's internal data and functions. These powerful capabilities enable faster development and increased efficiency while still achieving the highest level of safety and reliability.
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Medical Device Cloud Platform

CypherMed Cloud was built for medical devices from the ground up to support the unique requirements and capabilities that robust medical device cloud management demands. HIPAA, GDPR, CCPA compliant solutions ready to integrate with your advanced Medical Device.
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Regulatory Documentation

At Promenade we utilize a library of checklists and over 20 templates that have successfully been through multiple 510(k) submissions. We can assist you in completing your Design History File (DHF), compliant with FDA software and cybersecurity requirements, and IEC 62304.
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Why risk getting your product to market?
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Contact us to learn how our platform is built to reduce the risks, time, and cost throughout the entire product life cycle, from prototype through production.

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Cloud IntegrationMedical DeviceRegulatory complianceMed device cloud and regulatory gears
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U.S.-Based Software Engineering Experts

All of our our engineers hold C.S., C.E., or E.E. degrees or equivalent, with years of relevant experience. We never off-shore our work -  all work is done in the United States.
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How We Work Together

REVIEW

We provide verification reviews, code review, and test documentation for the Design History File (DHF). This ensures that the controls are in place and the software is of the utmost quality.

COLLABORATE

Our team of expert software engineers, work WITH you to refine requirements, recommend solutions, and create a sustainable software architecture to meet the needs of your project.

DEVELOP

We bring our breadth of software experience, knowledge, pre-validated libraries, and tools to ensure that your project will be developed efficiently and to the highest standards.

DOCUMENT

Using our ready-made templates and checklists, we provide the complete Design History File (DHF) for the software, compliant to FDA 510(k) and IEC 62304 standards. 

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What Our Clients Have to Say

"Promenade is a key partner for us. They helped us develop and remediate products with the best-in-class cybersecurity stance, which is extremely important for patients, our clinicians and for us, a medical device company."

Director of R&D
at Major Medical
Device Company

"We approached Promenade about creating an end-to-end solution software platform fully compliant with FDA requirements, quality systems management and FDA grade deliverables. Promenade gave us a spectacular product."

Dr. Erik Won,
President,
Wave Neuroscience

"Promenade Software was instrumental in helping DxTerity get our COVID-19 testing launched using their [cloud] platform. It allowed us to rapidly develop a secure and complex workflow to support both employee testing and for employers to be able to view the test results."

Tim Guyon,
Principal Scientist,
DxTerity

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530 Technology Drive, Suite 100
Irvine, CA. 92618
(949) 333-4634
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ABOUT
PROMENADE SOFTWARE

Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade's Quality Management System is ISO 13485 certified. Our Cloud systems are  SOC2 Type II certified.

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© 2022 Promenade Software, Inc.