Software Development

TriE can design for the most popular mobile platforms.

From embedded software to custom mobile applications, TriE can assist with all phases of your medical software development project.

TriE Medical is heavily focused on software development to meet medical device regulatory requirements, rigorous software validation, and software documentation necessary for FDA approvals.  We develop medical device software products for FDA Class II and Class III devices.  Our software team understands what it takes to successfully develop code that can be properly verified, validated, and documented for FDA 510K or PMA submissions.

We work in all operating systems from Windows, Linux, Android, and Apple iOS platforms and take projects on at any point in the software life cycle process from concept to market entry.  TriE Medical can assist your organization with the following software development needs:

  • Custom Software Development
  • Mobile/Smartphone Application Development
    • Android Development
    • iOS (iPhone/iPad) Development
  • PC Applications
    • Windows
    • Mac OS
    • Linux
  • Embedded Software Development
  • Graphical User Interface (GUI) Design
  • Database Development
  • Software Test Case Development
  • Software Verification and Validation
  • Software Documentation for CE Marking, FDA 510K or PMA applications.

Our software development activities are governed by the ever-changing, stringent regulatory requirements and TriE Medical’s Quality System.  Reference below for the standards we follow throughout the software development life cycle:

Standard Title
EN 62304:2006 Medical Device Software-Software Life Cycle Process
FDA PMA Guidance May 11, 2005 ODE Guidance for the Content of Pre-Market Submission for Medical Devices Containing Software
IEC60601-1-4 Programmable Electrical Medical System Specifications
Quality System Regulation (QSR) 21 CFR 820.30 Design Control Guidance for Medical Device Manufacturers

Contact the TriE team to get started!