Medical Device Testing

Medical Device Testing

Medical Device and QA Testing

We help staff protect patients, and themselves, with our medical device testers. We know that quality assurance (QA) is paramount in medical device testing, so our specialized equipment is made to enhance and streamline the QA process. We have been a leader in this industry for decades and don’t take that responsibility lightly.

Our team of experts is dedicated to developing reliable and accurate medical device testers. These products meet tough international and national safety standards and offer advanced features that go beyond what is required. Our top-of-the-line medical device testers are made with a user-friendly approach designed to simplify the complexity of testing making sure QA remains a top priority. 

Medical Device Software Testing

There are two main types of software testing: static and dynamic. Static testing combs over the code base to look for vulnerable code snippets and provide alternative, secure code. Dynamic testing looks for vulnerabilities in the running application through various types of testing. While static and dynamic testing have pros and cons, they are most valuable when used together.

Static Testing For Medical Software

Static Application Security Testing, or SAST, involves carefully analyzing source code to identify poorly written code segments. This is often done with a combination of automated and manual testing. Automated testing quickly parses the entire code base looking for known vulnerable functions or code snippets. Manual testing typically involves a more careful review of key sections that the tester identifies as critical. This may find some unique flaws that may have been overlooked otherwise.

SAST has the advantage of looking under the hood of an application and identifying problems that may otherwise be missed from an external perspective. This can find issues that are only accessible in certain niche situations by having full access to the source code. An excellent example of this would be how an application handles password encryption. Vulnerabilities in 3rd party components may come up in the future that allow an attacker to access passwords, and if these are not properly encrypted, it could be disastrous.

Dynamic Testing For Medical Software

Dynamic Application Security Testing, or DAST, is a security test of the running, functional application. This testing seeks to identify vulnerabilities using common frameworks, such as the OWASP Top 10 list. DAST is usually performed with both automated and manual techniques. Commercial tools can send malicious payloads at input fields across the application and perform parameter tampering to trigger an unexpected response. Manual testing will take the same attacks further and attempt to incorporate more difficult and customized attacks.

DAST will aim to attack an application from the outside like an outside attacker would. This can provide a realistic understanding of what attacks are feasible and likely to happen. Another great advantage of this type of testing is that it will often identify vulnerabilities only present from different components interacting with each other. These can be much harder to detect through code review, but experienced testers will be able to identify such niche cases.

Medical Device-Specific Concerns

Medical devices introduce a slew of unique problems not faced by other devices. This comes from often unique functionality and the unique data that they process. While the basic techniques will be similar, there are new considerations that the tester must address. Testing techniques will need to be modified to accommodate this. Unique functionality may take more customization to craft proper test cases to ensure adequate security.

HIPAA regulations mandate careful protection of sensitive data about patient information in the USA. Many medical devices will process and store this data, and care needs to be taken to ensure it is handled appropriately. Security standards are regularly evolving, and what was once considered secure may soon be deprecated. With this in mind, attention should be directed to sensitive data being stored or moved.

New medical devices can perform incredible, lifesaving tasks. In an evermore connected world, it is common for devices that were once entirely offline to have computers and some form of connectivity. This applies to highly critical devices such as life support systems that can cause death in the event of failure. Hackers that can access such critical devices can abuse vulnerabilities with massive consequences.

 

5 Types of Medical Device Testing Methods

Reusable medical devices have become an integral part of modern healthcare, aiding in the diagnosis and treatment of various conditions. However, before these products can hit the market, they must undergo strict testing methods to ensure their safety, efficacy, and reliability. Manufacturers must comply with regulatory requirements to produce high-quality medical devices that are safe and effective for both patients and healthcare professionals. We will explore a few different types of medical device testing methods and why they are crucial to ensuring your product is ready for mainstream use.

Usability Testing

Usability testing involves evaluating how easy and efficient it is for healthcare professionals to use medical devices. This selection of tests considers aspects such as patient safety, human factors, engineering, ease of use, and effectiveness. Manufacturers can perform usability testing in a simulated environment to identify user-interface issues and get feedback from potential users before launching the device. This way, you can ensure your product is as simple to use as possible and more likely to be effective in a real-world setting.

Material Compatibility Testing/ Functionality Testing

Material compatibility testing is especially important for reusable medical devices, as these devices will be used upwards to hundreds of times and device manufacturers need to establish a safe shelf life when devices are exposed to reprocessing conditions. Reusable medical devices require device design control testing of materials, systems, and finished devices to assure that the device and the materials it is comprised of are compatible with the various sterilization & cleaning listed in the devices’ labeling claims. This testing is comprised of running the device through multiple cycles of repeated exposure to cleaning and sterilizations processes. At time intervals, the devices will be evaluated for degradation. Functionality testing involves actuating the device and evaluating its features (physical, electric, etc.) after exposure to these processes. It is essential that healthcare professionals are using devices that are performing correctly, whether they are brand new devices, or have been used 50 times.

Biocompatibility Testing

For many medical devices, certain assessments and treatments require taking samples of a device material and observing whether that material makeup will cause a reaction within the body. Biocompatibility testing ensures medical devices are safe for use inside the human body. Tests such as cytotoxicity, sensitization, and intracutaneous reactivity ensure medical devices do not cause harmful biological reactions when in contact with body tissues.

Sterilization Efficacy Testing

In addition to biocompatibility, medical devices must also demonstrate the ability to be properly sterilized between uses and attain the necessary sterility assurance level. Sterilization is crucial to ensure the safety of medical devices and prevent infections. Depending on the type of device, manufacturers use different sterilization methods, including ethylene oxide, steam, and hydrogen peroxide. Sterilization can be performed using low-temperature methods (hydrogen peroxide, ethylene oxide) that use sterilant penetration to kill microorganisms, or high-temperature methods (steam) that use steam penetration. However, each method will not be compatible with every device. Device manufacturers will be responsible for choosing and validating a sterilization method that is compatible with their device design and material makeup.

Performance Testing 

Another type of medical device testing method to know about is overall performance testing. This is similar to usability testing except that it deals with how effective a product is in treating the specified illness or condition. Performance testing involves evaluating medical devices against established performance criteria. This test aims to measure the safety, efficacy, and reliability of devices during routine clinical use. Manufacturers evaluate performance through a variety of tests, including mechanical testing, electrical safety, and electromagnetic compatibility testing.

By investing in product testing, medical companies will reduce hazards associated with their devices and improve their safety parameters. As such, it is vital that you partner with a quality medical device testing lab to ensure you have all the information possible before release.  

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