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How to Build Custom Medical Device Software

Medical equipment software development requires considerable engineering effort and knowledge. It starts with defining project goals and scope while creating a profound medical device/software architecture. Let’s discuss the most important aspects of building medical device software.

A High-level View of the Medical Device App Development Process

SaMD development and embedded system development are associated with a wide range of medical device software development processes. That’s why they require different specialists, diverse engineering expertise, and well-qualified health-tech engineers to amalgamate the results.

Basically, from a top-level view, a medical device software engineering project requires the following actions:

  • Define the technological stack of your medical device software project: Is it a purely embedded/SaMD project, or mixed?
  • Identify and fulfill the FDA requirements for your type of medical device and software (in compliance with HIPAA.) Certain types, especially new medical equipment, require ISO certifications and compliance with other standards.
  • Based on your project scope, hire or gather a team of developers capable of embedded and/or conventional software development, which is required for SaMD development.
  • Let a health-tech engineer design your software/device system specifications.
  • Make sure a skilled project manager is assigned to break down the project into distinct phases and tasks.
  • Assign these tasks to the right specialists: health-tech UI/UX designers, back-end/front-end developers, QA specialists, and others.
  • Make sure you have medical professionals available for consulting and testing. Remember that medical staff (physicians, nurses, surgeons) and their patients are expected to be the end-users of your medical product, so their interests should be represented.

Tech Stack to Use in Medical Device Software Development

There exists a great abundance of technical solutions and tools that can work for medical equipment software development. Your specific configuration depends on your project and its scope (which should be discussed and specified with your vendor). If you want to discuss specific tech options and the medical device software development process with an expert, please contact us for a free consultation.

The average tech stack used in medical device software engineering can include a mix of anything from the list below:

  • Integrated Development Environments (IDE) and Compiler
  • Embedded coding languages: C, C++, Python, MicroPython, Java
  • Debug Devices and Software (Debugger)
  • Emulators
  • Testing Software and Devices
  • Cloud development: Azure, AWS, Digital Ocean, Google
  • Integrated health tech solutions with wearables, mobile, and IoT devices
  • Front-end development: Angular, React, Vue, Node.js, and Core JavaScript
  • Supportive Software: C#, Node.js, JavaScript, TypeScript, Dart, PHP, and SQL
  • Middleware and additional modules from a variety of vendors: 3D imaging, 3D printing, AI, ML, AR/VR, medical SaaS, and more.


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