Software for Medical Devices

Modern medical devices, such as surgical robots, x-ray machines, or laboratory equipment for in-vitro diagnostics, mainly consist of software. We develop your medical device software in compliance with applicable standards and laws, such as IEC 62304, ISO 14971, IEC 62366, and the Medical Device Regulation MDR, to ensure smooth approval of your medical devices.

Of course, our quality management system is certified according to DIN EN ISO 13485.

Suitable and agile development processes following TIR45 from the requirement to the release become essential to master rising complexity and increasingly shorter release cycles. Short feedback cycles allow you to quickly implement required changes with high quality and in compliance with processes.

With professional Medical Device Software Engineering ...

  • you receive software developed in compliance with standards for your medical product
  • you implement changes quickly & compliant
  • you derive active benefit from our regulatory expertise
  • you do not compromise quality

Medical Device Software Engineering Services at Method Park

  • Software development for medical technology in compliance with the applicable standards & laws
  • Definition of standard-compliant & agile development processes
  • Identification of user requirements
  • Support in the implementation of risk analyses
  • Paving the way to compliance with the Medical Device Regulation

Any Questions?

Any questions about our engineering service offers? Feel free to call us!

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The right composition for your project

Programming languages

  • C / C++14 / C++17
  • C# / .NET / .NET Core
  • Python 2 & 3
  • Java
  • TypeScript / JavaScript
  • HTML5
  • POSIX Shell / Bash
  • Rust

Frameworks

  • Qt5 /QML
  • boost
  • Entity Framework
  • Ranorex
  • Nunit / cxxunit
  • Redux
  • Bootstrap
  • Linux-Kernelmodule
  • Angular
  • Node.js

Standards

  • IEC 62304 / IEC 82304
  • ISO 13485
  • ISO 14971
  • IEC 62366
  • FDA 21 CFR part 820

Databases

  • PostgreSQL
  • MongoDB
  • MySQL
  • MSSQL

Processes

  • Scrum
  • Scaled Agile (SAFe)
  • AAMI TIR45 compliant

Tools

  • Git
  • Jenkins
  • Gitlab
  • Clang + LLVM
  • GCC + GNU Binutils
  • Cmake
  • yocto
  • aptly
  • GDB
  • Packer / Terraform /Ansible
  • Docker / Podman
  • Kubernetes
  • Valgrind
  • Eclipse
  • Visual Studio Code
  • Qt Creator
  • Visual Studio / TFS / Azure DevOps
  • ReSharper
  • Jira
  • Testbench