Medical – Prolucid

ISO 13485 Certified Software Design, Development & Maintenance

Over 18 years of developing custom software applications for customers in the medical technology industry

ISO-13485 Certified Software Design, Development & Maintenance

Over 18 years of developing custom software applications for customers in the medical technology industry

18+

years of experience

16+

clinical areas supported

285+

projects completed

>95%

repeat customers

We’re highly specialized in specific technologies across many application types.

Imaging & Diagnostics

Application of advanced image processing and computer vision algorithms that significantly advance traditional diagnostic capabilities.

Machine Learning & AI

Integration of ML/AI algorithms including data collection, labelling, model development, and deployment under full design controls.

Cloud & Connected Devices

Development of custom cloud portals and applications including device connectivity & management, real-time data collection & storage, and powerful visualizations.

SaMD

Creation of powerful software-as-a-medical device applications for diagnostics, therapeutics, and remote patient monitoring and engagement.

Embedded Systems

Build custom embedded software applications for device control, data acquisition, processing, user interfaces, and wired & wireless connectivity.

Custom Integrations

Integration with EHR, PACS, and RIS applications, as well as existing devices, monitors, and hospital infrastructure.

Imaging & Diagnostics

Application of advanced image processing and computer vision algorithms that significantly advance traditional diagnostic capabilities.

Machine Learning & AI

Integration of ML/AI algorithms including data collection, labelling, model development, and deployment under full design controls.

Cloud & Connected Devices

Development of custom cloud portals and applications including device connectivity & management, real-time data collection & storage, and powerful visualizations.

SaMD

Creation of powerful software-as-a-medical device applications for diagnostics, therapeutics, and remote patient monitoring and engagement.

Embedded Systems

Build custom embedded software applications for device control, data acquisition, processing, user interfaces, and wired & wireless connectivity.

Custom Integrations

Integration with EHR, PACS, and RIS applications, as well as existing devices, monitors, and hospital infrastructure.

We have a proven, collaborative, and customer focused approach.

Let’s Connect

Industry Experience

We have successfully delivered a wide variety of in market medical applications, and bring this experience to every project that we support.

Cybersecurity & Regulatory

We review and understand each projects unique quality, cybersecurity, and regulatory needs and ensure these requirements are fully met.

Technical Expertise

We are experts at a wide variety of software tools and technologies and use the best ones for the problem you are looking to solve.

Ongoing Support

We can help with ongoing maintenance and support, or enable your team to manage internally through transfer of knowledge and training.

We have a proven, collaborative, and customer focused approach.

Industry Experience

We have successfully delivered a wide variety of in market medical applications, and bring this experience to every project that we support.

Cybersecurity & Regulatory

We review and understand each projects unique quality, cybersecurity, and regulatory needs and ensure these requirements are fully met.

Technical Expertise

We are experts at a wide variety of software tools and technologies and use the best ones for the problem you are looking to solve.

Ongoing Support

We can help with ongoing maintenance and support, or enable your team to manage internally through transfer of knowledge and training.

Let’s Connect

We are passionate about making a difference in patients lives.

We bring structure and order to even the most complex projects and have a proven track record of helping our customers bring new medical technologies to market.

Contact Us

We are passionate about making a difference in patients lives.

We bring structure and order to even the most complex projects and have a proven track record of helping our customers bring new medical technologies to market.

Contact Us

FAQs

Do you have a QMS?

We are ISO 13485 certified for software design, development, and maintenance. We can complete your project under our QMS, or if it is simpler to work within yours than we can do that as well.

Who owns the IP and Data?

Our customers own any custom developed source code, project specific IP, and related data. In some cases we incorporate open source libraries, and we review the licensing terms together with your team to make sure there are no concerns with the project.

Do you support with documentation and testing?

As part of our IEC 62304 development process we can help with the full documentation package including requirements, design, architecture, test procedures, traceability matrix and more. On the testing side we typically complete the software verification testing internally and then support with validation testing as needed.

Do you support with Cybersecurity & Data Privacy?

We follow a secure software development lifecycle from design and development through vulnerability assessments and ongoing security patch monitoring and maintenance. We also support with cybersecurity risk assessments, and data privacy best practices for regulated industries.

Do you support with hardware design?

We don’t design hardware in-house, but we have a network of partners who specialize in hardware design & product development and are happy to share intro’s within our network.

What types and stages of projects do you support?

We support projects of all stages and sizes, including technology assessments, design, prototyping/proof-of-concept, full commercialization, and legacy project support. Let us know what you are working on and we are here to help!