Why test your software before market release? The answer is that testing can help lower costs due to unforeseen consequences of medical software. Testing medical software will ensure that it works efficiently, properly, and effectively with users. Moreover, detecting critical bugs and security issues with software will make it safer for patients and healthcare personnel to use.

The key to smooth testing are comprehensive documents and proven medical device test engineers. With over 550 projects completed since Sterling’s founding, Sterling has seen many different types of devices and software including Class I, II, and III software. Our extensive knowledge will ensure your software is properly tested and that mitigations to those risks are found.

Sterling Medical Devices is committed to making sure that every aspect of your medical device has been tested, verified, and validated. Our engineers work with you to help ensure a thorough job in defining requirements in the initial stages of your medical device development process to uncover hidden details as early as possible in the process.

Smart, cost-effective software verification services for medical device companies

What is happening nowadays? What mistakes do companies usually make?

Many medical device developers struggle to adhere to FDA and EU regulations because they leave software verification until after the device has been developed. This results in sloppy submissions and unnecessary stress due to rushed retro-documentation and the late discovery of bugs.

Software verification detects errors early on, thereby increasing productivity and shrinking the development timeline. Software verification also prevents malfunctioning products from going on the market, saving the company from legal issues and a ruined reputation, and most importantly, ensuring patient safety.

Sterling Medical Devices can provide software verification testing services at any stage in a product’s lifecycle. We also emphasize software verification during the design phase for our clients in order to develop medical software the right way, the first time.

What is medical device software verification? Why is it necessary?

The FDA Quality System Regulation requires design verification. Design verification confirms that ” design output meets the design input requirements”*. In order to prove verification, the FDA mandates objective evidence that proves each design element is completely satisfied and traceable to requirements. In the case of software, this objective evidence is provided by the software verification process. Software verification ensures that design outputs meet input requirements at each stage of the software development lifecycle, essentially confirming that the product is being built correctly.

Verification is necessary if software is present as:

  • a component of the device
  • the device itself

Independent medical device software verification from a trusted partner

What makes Sterling different? What does Sterling do?

Sterling Medical Devices maintains your timeline and budget while keeping you involved in the verification process. Our team of experienced engineers test software for consistency, completeness, and accuracy, maximizing the chances of an FDA approval on your product.

Our software engineers use verification testing, and source code analysis while developing your medical device software to reveal bugs early on and to avoid large workloads at the end of development. We have licenses for state-of-the-art verification tools that further supplement our work. To support your submissions to regulatory agencies, we also provide independent software verification activities including:

  • Source code evaluations
  • Software testing
  • Module level testing
  • Developing Supporting Documentation (e.g. design history files, or DHF)
  • Static and Dynamic Analyses
  • System Testing
  • Unit Testing
  • Integration
  • Code Reviews
  • Regression Testing
  • Verification Reporting