A medical device manufacturer meets mission-critical regulations with Xray

Xray gave us full traceability of the requirements from specifications to test plans and test results.  As a medical device manufacturer, Xray helps us maintain compliance with regulations while saving us development effort and cutting reporting time by 50%.

Ron Kurtz – VP of Engineering at MyndTec

Medical device manufacturers operate in an increasingly regulated environment. These companies have a unique set of challenges with how they design, release and operate their products. Companies in this industry must meet strict safety regulations to ensure the safety of their users. If their projects don’t pass all regulations, they simply don’t get released. 

Testing for safety and quality regulations include predefined checklists and strict documentation. Without a test management tool to ensure requirements are thoroughly met, and compliance documentation is complete, the process is burdensome and unpredictable.

MyndTec, a medical device manufacturer from Canada, found the optimal solution to their unique industry challenge with Xray and Xporter. 

With Xray, they meet all regulations from requirement traceability to the design and development. They also take advantage of risk management to ensure quality meets standardized protocols. With Xporter, a reporting app that integrates with Xray, they create quick and powerful reports that they submit for review with just a few clicks. 

Read on to understand how MyndTec uses Xray and Xporter to meet strict regulations with full requirements traceability and cut reporting time by 50%.

About MyndTec

MyndTec develops technologies designed to improve function, and maximize the quality of life for individuals with paralysis due to stroke or spinal cord injury. For each one of their products, they have to re-certify for their regulations and pass regulations like the ISO 14971 and ISO 13485 annually. 

As both a hardware and software product, they have many complex requirements that are all interconnected and dependent on each other; that’s why having traceability all the way back to the requirement is crucial. 

Here are the 3 most common challenges all medical device manufacturers face:

The Challenges

1. Meeting strict regulations by the FDA

The FDA and the European Union require medical device manufacturers to present specific documents that include all of the engineering documentation, product requirements, risk analysis, and test protocols for validation and verification. They also require all of the change records which demands precise traceability. 

MyndTec specifically has to comply with the ISO 14971 which is an ISO standard for the application of risk management to medical devices. Every 6 months they have to do a validation test and submit the results. 

Ron Kurtz, VP of Engineering tells us that before Xray, they used traditional methods of QA like spreadsheets. He says it was nearly impossible to manage everything on Excel. To produce traceability information and compliance reports was manual, extremely time consuming and prone to errors.

2. Comprehensive risk management and requirements traceability

Teams who use Word & Excel for their test management do not have traceability to effectively manage risk. All medical device companies need to have established risk management processes that comply with ISO 14791. Risks must have traceable design artefacts like requirements and design specification that can easily tracked and updated. 

Before MyndTec started using Xray, they weren’t able to have the visibility and traceability that Xray provides to easily manage risk and show proof of requirements traceability. They needed a tool that would simplify this demanding process of documentation and provide proof of traceability.

3. Complex Software Development Lifecycle

There is always an added layer of complexity when software needs to be tested for risk and safety compliance. Testing both hardware and software is challenging as it includes many requirements that are interdependent on each other. When it comes to medical devices, they have a special component which is the addition of software. 

It’s important for all team members to be able to trace back to requirements and make the necessary changes. Visibility into status of projects is also important as it provides a means to ensure the timeliness of the project. 

The Solution

In these safety critical environments, Xray equips medical device manufacturers like MyndTec with solutions to their biggest business challenges. 

Ron Kurtz tells us that they were early adopters of Xray, and he started using the tool in 2015. “At my previous company, (also a medical device manufacturer), testing was also done with Excel and I was looking for a better way to manage our testing. Xray met my requirements, and it was especially important that it had the integration with Xporter so that I can use it to make reports and documents for auditing.”

At MyndTec, he was certain that he wanted to use Xray and Xporter. To onboard, he imported their existing tests into Excel in less than a week. Now it’s been 5 years since MyndTec adopted Xray and Xporter and the solution meets all of their needs.

They’ve reduced their efforts and time with documentation by half, overall increasing their efficiency with designing, building and testing their product. Here are their 3 biggest takeaways: 

1. Streamlined documentation and compliance reporting

“Previous to Xray, we were using only Excel to manage our tests and results, but that became impossible the more tests we had. Now we build advanced reports, with requirements & test coverage. I can export testing documents with a click of a button. With Xray and Xporter, our test documentation is 50% faster.”

Ron Kurtz – VP of Engineering

Xporter has a native integration with Xray which makes it simple and easy to create fully customized documents in many different file formats like PDF, DOC, XLSX, etc.

Ron tells us that once they set up their documentation template, they produce their reports with just a click of a button. This way, they easily send their documents to the ISO for verification and end the lengthy process of manually recording results.

2. End-to-end requirements traceability

For device manufacturers, requirement traceability is one of the most important parts of their compliance and audit report. Currently, MyndTec produces verification reports that show the results of all of the tests. They also use the traceability report which gives them full visibility through all of the changes of traceability.

Xray’s traceability report shows the requirements traceability through tests, test runs and defects. It supports 3 levels for requirements (e.g. epic=>stories=>sub-tasks), and allows you to track the coverage at multiple levels. With this level of traceability they also have real time visibility into the status of their release and readiness to deploy. 

They also use the Overall Requirements Coverage Report. This report allows you to analyze your requirements statuses in real-time. This way you can easily evaluate the coverage status for a given version, and understand the completeness and progress based on the respective testing results. 

3. Effective risk management and analysis

“We use Jira to track all of the product requirements and product risks. Then we document in Jira all of our requirements, break them down into both software and hardware requirements.”

Ron Kurtz – VP of Engineering

Currently, Ron tells us that they link risk mitigations to requirements and then tests the requirements. This way he can get full traceability and proof that all mitigations have been verified and that the residual risk levels for the product are low. 

They use R4J to capture all the requirements, specs and risks, with a different type for each. Each risk mitigation is linked to requirements or specs, which in turn links to tests.

Xray also allows you to define risk at the project level, requirement level, and directly at the test level.

The Results

Meeting safety regulations is mission-critical for MyndTec, and with Xray, they ensure speed, efficiency and compliance. 

Medical device manufacturers know that quality is priority and everyone in the development life cycle must actively participate to ensure quality. For MyndTec, Xray is the perfect solution since it is tightly integrated with Jira, the leading agile project management tool.

They use Xray to ensure they’ve tested every requirement and regulation. With Xporter they quickly produce reports that show end-to-end requirement traceability and easily submit to the ISO for auditing. 

This way, their medical devices can comply with regulations, serve their purpose and help thousands of individuals worldwide recover from the debilitating effects of a stroke.