Medical Devices

Efficiently build safe, reliable, and secure software.

There's no software more crucial to human life than the software that powers medical devices.

From software used in the doctor’s office to life saving medical devices, software has infiltrated every aspect of medicine. Today’s medical devices look drastically different from “big budget” clinical devices – many are affordable consumer devices and wearables. But the complexity of these new medical devices continues to rise exponentially, with more security, privacy, and reliability issues, FDA (or country-equivalent) approval, and costs.

FDA guidelines have a “least burdensome” approach meaning they don’t want to force you to add intrusive and expensive processes to build your software. Instead, they want to ensure that you are following standard best practices such as managed requirements, traceability, unit testing, static analysis, etc.

Parasoft has an integrated toolkit for C/C++, Java, and .NET applications that supports a broad range of these best practices that are proven to improve software safety and reliability. Parasoft provides static analysis and unit/component testing with comprehensive code coverage analysis, requirements traceability, and tool qualification kits. These solutions will help you reach compliance with IEC 62304 driven quality expectations.

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Software on Medical Devices is Governed by IEC 62304

IEC 62304 is a highly recommend standard by the FDA for medical device software development. As such it outlines, at a high level, a software development process driven by risk management for increased device safety.

The tricky part of it is that testing devices can be really complicated. There might be a whole ecosystem you need to standup just to test, and if the device is interacting with humans it’s trickier still. Parasoft Virtualize lets you quickly and easily stand up whatever test environment you need and perform end-to-end testing of a device in its environment – even if other pieces of the system aren’t available or aren’t finished yet.

Other Medical Software is Controlled by IEC 82304

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

IEC 82304 governs the rest of medical software – in a nutshell, things that run on a general-purpose computer – like your PC. This covers things that run in the doctor’s office, online medical applications and the like. You want to make sure the software is accurate and reliable, and of course secure.

Security and Privacy

HIPAA and GDPR govern privacy guidelines, and in both cases, “Secure by Design” is the key. It's important to build your software with the idea that you need to protect important user data from the beginning, with encryption, proper access and security controls, and solid coding practices.

The FDA recently recognized the new standard from Underwriters Laboratory UL 2900 as a cybersecurity standard for medical devices. This gives you good static analysis guidelines for securing your software and protecting patient data.

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Addressing the Challenges of Increased Connectivity

Hospitals are connected like never before – every monitor, every pump, every draw containing medicine is connected, and each connection represents an additional level of complexity that needs to be tested for both testing the application itself and making sure it is safe from the risk of compromised or malfunctioning devices that it is connected to. Testing how your application operates within this complex system of connected things is difficult. Parasoft's suite of tools simplifies the testing of today’s highly-connected devices by blending API testing (via Parasoft SOAtest) and device level testing (via Parasoft C/C++test) coupled with a controllable test environment (powered by Parasoft Virtualize).

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Parasoft's Comprehensive Solution for Medical Devices

Parasoft C/C++test

Parasoft DTP

Parasoft SOAtest

Parasoft Virtualize

"Parasoft is on the leading edge of automated testing. Developing software without using an automated software testing solution that finds bugs and design flaws during the development cycle is like developing software in the dark ages. With Parasoft Embedded solutions, we find and fix software issues in the development stage long before the QA department starts testing the code."

- Bovie Medical

"Parasoft support trained us for one week and we were able to take it from there. We quickly saw that the product had a lot of powerful features that would help us automate our testing activities and processes. Parasoft SOAtest was able to support all the latest standards (ex. security and schema validation standards); we were able to test all areas of our APIs."

- MedicAlert

"With Parasoft’s solution, previously arduous, boring and difficult-to-document tasks were transformed into tasks that we could perform systematically — in an automated and rapid manner."

— IMA

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Find out how Parasoft's solutions for medical device software development can help your team.

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