Developing safe, effective medical device software

Medical device software development is growing increasingly complex in design and functionality to match the growing need for enhanced patient care and therapies. Now more than ever, you need a trusted and experienced partner who can guide you every step of the way in your medical device software development process.

Sterling Medical Devices can step in at any stage of your development lifecycle to help you develop a safe, effective, and FDA / IEC 62304 compliant medical device product. We work closely with you and your team to understand every aspect of your design, development, and testing needs to help ensure a quality Class I, II, and III medical device product.

We can help you with any step in the medical device software development process, including:

  • Full life-cycle development
  • Software verification and validation testing
  • Design History File (DHF) Remediation
  • Expert testimony
  • Independent medical systems verification/validation to support your submissions
  • Unit module testing and integration testing
  • FPGA design and development
  • Algorithm development


Specializing in medical device software development since 1998

Sterling Medical Devices is ISO 13485 certified and we work with medical device companies throughout the entire software development lifecycle using state-of-the-art tools. We help you to align your medical device software development efforts with FDA expectations and gain faster regulatory approvals. And we can help you move toward best practices, such as leveraging safety assurance case principles to clearly demonstrate the safety of your medical device product.

Sterling is ISO 13485 registered and compliant with the following standards:

  • IEC 62304 – The FDA recognized CE Mark requirement for medical device software development.
  • ISO 14971 – The standard for managing risk for medical devices.
  • IEC 60601 – A series of technical safety and effectiveness benchmarks for medical electrical equipment.


Risk-based approach to medical device software development

Software nowadays, is ever more critical to the operation of medical device products. In fact, if software in a medical device can be defined as an instrument, apparatus, implant, in vitro reagent, or accessory, then according to the FDA, the software itself can be designated as a medical device.

While innovation in medical device software design gives rise to new medical device developments and breakthroughs, it also creates new concerns about safety and effectiveness. According to the FDA, most medical device recalls can be attributed to software design failures. And when software as a medical device fails, patients are at risk. What’s more, medical device security is a growing concern.

A trusted partner like Sterling Medical Devices can help you address your software design challenges and help you streamline the process of having your medical device product reviewed by the FDA. We work with you to understand the intended use and requirements of your medical device software to establish the foundation for safe, secure, and compliant medical device products.


Dedicated, experienced team committed to efficiency and transparency

Our full-time engineering team has a wealth of experience and their focus is on ensuring the job is done right the first time. We help you determine your software level of concern, ensure your software is 100% safe, and that it meets all necessary standards to pass the required regulations.

Whether serving as your full-time development team or aiding your current team in any phase or area of need – from documentation and testing, to risk management and development – our staff keeps you up to date, informed, and involved in every step along the way. Our team champions efficiency throughout the software development process, leveraging best practices and tools to manage risk and stay on schedule.

What’s more, you’ll feel safe knowing the Sterling team you’ve come to rely on during your project will be there to call on again, even after the project is finished.


Learn more about our medical device software development services. Call 201.227.7569 ext.2