Medical Device Testing: Top 4 Methods

By Vitaly Prus, Head of Software Testing Department, a1qa
Twitter: @A1QA_testing

Medical wearables device development is a dynamic field. According to eMarketer, over a quarter of the US population will use smart wearables by 2025. Besides, Market Data Forecast reports the size of the US wearable medical device market will reach $8.2 billion by 2028. This data proves the growing demand for safe and compliant medical devices to enter the market.

However, the healthcare industry has strict medical device standards (IEC, ISO) and FDA regulations, triggering the need for high-quality medical device testing services. Let’s explore the specifics of consumer medical devices and learn how to test them efficiently.

What are consumer medical devices?

These devices include health monitoring tools (to check blood sugar level, heart rate, glucose, and blood pressure), connected inhalers, wearable ECG monitors, and smartwatches, among others. They gather and analyze users’ health data, like vital human body parameters or body temperature, store it in a secure cloud, or transmit it to mobile phones and tablets, and support data sharing with web apps and doctors when requested.

Medical devices, such as pulse oximeters, saw a rise during the coronavirus pandemic. At that time, wearables and medical monitoring devices provided users with a unique opportunity to manage their health proactively without the risk of going to highly contagious areas.

However, when the pandemic subsided, consumer medical devices didn’t lose their appeal for users. Now they are actively used to monitor chronic conditions or health parameters continuously. But, medical devices should undergo extensive software testing and approval processes to work correctly. So, how can manufacturers ensure their fail proof performance and security?

Launching flawless medical devices: four major software testing methods

1. Functional testing
When testing medical wearables’ functions, ensure the software works as described in the specification. Healthcare devices have a precise set of features you should test. They involve measuring health parameters and sharing the data with third parties. In addition, it’s vital to run manual exploratory testing by reproducing real conditions, using anonymous data from laboratories and medical centers, and emulating the connection between the IT products and the human body. It helps address some functional glitches users can experience before the release.

2. Compliance testing
Software as a medical device solutions (SaMD) affect a person’s health and require compliance with the healthcare industry standards as well as the FDA and MHRA and other international certifications.

Industry standards
Medical devices should, with some exceptions, comply with the global standards ISO 14971 and IEC 62304. The standards specify risk management for software as a medical device (SaMD) and outline the device lifecycle. By adhering to international standards, SaMD developers can attest to their product’s superior quality and safety.

FDA and MHRA certifications
In developing remote patient monitors and smart wearables, programming engineers should rely on FDA and MHRA and other international regulations. The team should draft an explicit and straightforward product definition to ensure the FDA or MHRA approval. Besides, the team should:

  • Clearly explain the intended use of the product
  • Assess various risks, assuring the product’s safety
  • Run QA and verify that the chosen implementation scenario fully covers users’ needs

QA experts recommend going for the FDA or MHRA certifications when the development is at the final stage. If you hurry, the rework loop can increase the time to market.

3. Security testing
Consumer medical devices collect personal health data, which attracts malicious actors. In addition, some devices can be connected to the internet, while the connections may lack security protocols and safeguards. You should implement additional protective measures to prevent the leakage of medical information.

First, you should ensure data transmission security. One of the ways to do it is by providing end-to-end encryption. In this case, even if hackers gain access to protected health information (PHI), they can’t use it as they only see senseless code instead of PHI.

You should also establish cybersecurity testing practices. When conducted regularly, vulnerability scanning helps detect weak links in the system and fix them before an attack occurs. It is critical to perform it after updates and any changes made to the application. Penetration testing allows identifying security loopholes and patching them timely.

Cloud solutions are also vulnerable to cyber threats. According to Thales Security Threat Report 2023, 81% of users trust their data to their cloud systems. However, 37% of them experienced a breach in the last twelve months. In addition, according to the 2023 global survey of Chief Information Security Officers (CISO) by Statista, about a third of participants consider cloud account compromise among the top cybersecurity threats of the year. Hence, advanced cybersecurity measures are needed.

You should also promote security practices among users. Monitoring the device’s behavior for any suspicious activity is paramount. For example, they can notice an abrupt mobile data transmission rate boost. In addition, they should avoid public Wi-Fi networks and connect to the internet using their medical wearable device only in safe and secure environments.

4. UI/UX testing
These testing methods help evaluate the experience users get when interacting with SaMD solutions and ensure that the product is easy to use and navigate as well as has no visual bugs.

  • UI and usability testing. The device’s features and capabilities should be intuitively clear to users. All actionable items – check boxes, buttons, and icons – should work well and be visible on the screen. The tool’s navigation should be simple and intuitive. Ensure the solution employs native large or thick fonts to prevent readability issues. In addition, you should verify the use of consistent colors in the layout. It reduces cognitive load and makes the tool more user-friendly.
  • UX testing. It assesses how easy it is to use the device. The touch and left-right swiping are the main gestures allowing users to interact with the solution. You should evaluate the gestures’ responsiveness. It would help if you also made sure calls and notifications the device receives appear in the background. They shouldn’t interrupt the device’s core functions.


People increasingly use SaMD tools to keep abreast of their health and take the necessary precautions. To operate seamlessly, be secure and easy to use, medical devices should correspond to all the security standards and undergo profound testing and quality assurance. The QA strategy should involve functional, compliance, security, and UI/UX testing.

A reputable QA agency can facilitate this process, ensuring smooth and timely market entry for medical devices.