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medical device
Software Development
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We Reduce the Risk, Cost and Time It Takes to Get Your Medical Device to Market
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We have services, experience and infrastructure to rapidly get your medical device to market

Your trusted source for medical device software from embedded to cloud

Embedded
Development

From low level firmware and embedded GUI applications,  we have the know-how to provide complete, robust solutions. Our Parlay framework also provides unequaled visibility and control of the embedded system during entire device life-cycle.
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Mobile
Applications

Whether your app is a SaMD or you are wirelessly connecting to a medical device, we have the framework, experience and regulatory expertise to get your mobile application to market efficiently and effectively for iOS and Android.
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Cloud icon

Web
Applications

Our team of experts can get your web application up and running quickly utilizing our certified CyberMed∙Cloud solution. From collecting and displaying device data, to complete user workflows and permissions, we can realize your cloud needs.
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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 verified frameworks and infrastructure required to simplify productization of medical devices

Medical Device Firmware

Parlay is designed for the stringent needs of medical devices.  The Self-Instrumenting codebase and libraries provide unmatched visibility and access to the system 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

CyberMed∙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 requirements and IEC 62304, including Cybersecurity.
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Why risk getting your product to market?
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We have developed an integrated platform of solutions that help our clients get their medical devices to market quickly and cost effectively.

Contact us to learn how this platform is built to reduce the risks, time, and cost throughout the entire product life cycle, from prototype through production.

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Engineers Engineering & Testing

U.S. Based Software Engineering Experts

We provide a full suite of software engineering services for medical devices and other connected embedded systems.
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How We Work Together

REVIEW

We provide several verification reviews, from code to DHF documentation. Which ensures that the software is efficient and  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 and development 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. 

GearArrows3/4Gear Base

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 delverables. 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 CyberMed•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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Featured Articles

Software As A Medical Device (SaMD) Regulatory Considerations

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Medical Device Development - Prototype Through Production

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16 Technology Drive, Suite 100
Irvine, CA. 92618, U.S.A.
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ABOUT
PROMENADE SOFTWARE

Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is ISO 13485 and 9001 certified.

American Systems registrar
© 2021 Promenade Software, Inc.