Ensure the reliability of your medical products

Our modern-era QA methodologies help you discover and fix software defects affecting long-term product reliability, while systematically collecting FDA objective evidence.

Make QA a breeze

Getting medical devices ready for market is not easy. Not only do you need to meet the requirements set by regulators; the devices themselves are complex by nature and often communicate with external entities like sensors and cloud services.

Ensuring the functionality and reliability of such systems often results in complicated and slow quality assurance processes with lots of manual work involved.

What if there was a way to make things more automated and agile?


FDA objective evidence

Collect the objective evidence data for regulatory agencies automatically during QA runs; your documentation proof will be complete and nothing is missing.

E2E scope

By including external devices and backend systems in the QA scope, you avoid nasty integration surprises that often occur close to product launch, or when the device is already on markets.

Continuous monitoring

You get constant quality feedback on your latest SW builds: how well do you meet the requirements, and is there any regression happening?

CI/CD integration

The QA suite, integrated with your CI/CD system, provides immediate developer feedback when a change is made. This enhances the overall quality of your software baselines, and speeds up development cycles.

Global audiences

Your customer base is global, and so is our approach: all language variants are included in QA scope.

Cost savings

Automated regulatory data and quality monitoring saves money, as the amount of manual work is reduced and the probability of human errors goes down.

Profilence quality analytics solution

Profilence Quality Analytics Suite integrates with your existing product, quality management, and software engineering solutions, and can be tailored and expanded to meet your specific requirements. It is complementary to your well-tried testing structures.

When all QA data is consolidated and available in a web dashboard, it enables efficient debugging and fluent cooperation between developers and product management globally, while collecting and storing data needed for regulatory approvals.

In the long run, our solution accelerates your product development practices and leads to faster time-to-market.


As someone working in the medical segment where quality and regulations play a significant role, maintaining QA and staying up-to-date is crucial. Profilence has provided us with methods to achieve just that. We highly appreciate their expertise and their dedication to ensuring our operations meet the required standards.
Jussi Määttä, CEO, Buddy Healthcare

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