Medical Device Software Testing

To Help You Deliver Safe Devices, Every Time

Faulty medical device software might trigger expensive FDA recalls, jeopardize safety, and make your device doubtful. Our rigorous medical device software testing services are your best protection.


Proven Approach To Medical Device Software Testing And Quality Assurance

The regulatory bodies have developed official specifications for medical device software to safeguard high-quality standards and protect patients from wrong diagnostics and consequently improper treatment. So the specifications mainly revolve around the accuracy of diagnostics, safety, and high performance.

That’s why medical device manufacturers should monitor products’ quality throughout the software development process and during transportation and implementation as well for quality assurance (QA).

Folio3 medical device software testing is done by professionals through innovation, superior resources, and testing expertise. This means we’ll assure top performance of your medical device software for maximum credibility and patient satisfaction.

Your medical device software testing will be done step-by-step to:

We are known as a top USA-based mental health app development company because of how we maintain our focus on our solution and provide reasonable mental health app development packages. We cover the minutest details when taking requirements from you in a detailed discovery program where we ask about the challenges you want to address and the goals you have in mind and make them our goals to achieve.

And this is not it. Our medical device software services are tailored to your needs to launch your device in the market quickly with 100% compliance.


benefits we provide

Failure-proof Your Medical Device With Medical Software Testing and Quality Assurance

The software quality assurance process and generation of related documentation is a tedious and time-taking chore that distracts the medical device manufacturers from the actual development process.

This is when third-party services and software testing services come to the rescue. A trustworthy software testing team streamlines and accelerates QA processes and also increases efficiency. As a medical device manufacturer, you can reap the following benefits from apt medical device software testing:

And this is not it. Our medical device software services are tailored to your needs to launch your device in the market quickly with 100% compliance.
solution we provide

Cutting-edge Testing System To Fault-proof Your Medical Device

Medical device software testing services by Folio3 have supported dozens of leading brands, mainly in the US. Our professionals have a unique understanding of the complexity of medical devices that occurs due to the complex integration of the ecosystem of hardware and software.

You will get end-to-end medical device testing tailored according to your needs and the requirements of compliance authorities as well.

Verification And Validation

Our team will optimize your V&V efforts, and also document those efforts in a way that will be FDA-compliant for maximum transparency.

Performance Testing

We integrate performance engineering into your CI/CD pipeline so bottlenecks are detected early in the SDLC to identify any possible issues and resolve them.

Load Testing

We will test your medical device at high loads to assure reliability, responsiveness, and compatibility at all times without any delay and error.

Usability Testing

We will test your device to ensure its design and user interface satisfies the government standards for safety and ease of use for increased customer satisfaction.

Cyber Security

Cyber engineers at Folio3 build security into every stage of your system development lifecycle to spot vulnerabilities instantly and mitigate risks.

Handling Of Errors

We evaluate your product’s performance under critical conditions to check self-regulation and fault-tolerance features for maximum credibility.

Interested in best-in-class medical device software testing?

Our Work In Medical Health

See our Award winning Work!


Mood Based Therapy App


Brain Health App for Alzheimer's

Trailhead Counseling & Grief Service

Trauma & Anxiety App


Digital Therapeutic Solution for Autism

Are You Looking for The Best IoT Healthcare Solution?

We help in delivering quality healthcare to your patients with the help of state-of-the-art IoT solutions for healthcare projects.

Frequently asked questions

Want to know more about the Medical device Software Testing?

The process of medical device software verification and validation includes: 

  • Make a validation plan 
  • Determine your system requirements
  • Create a validation protocol and test specifications
  • Conduct and document tests
  • Write final report

Medical device software verification validation and compliance include IEC 62304 which specifies software lifecycle development requirements for medical devices. Compliance with the standard is mandatory in Europe and it is recognized as a consensus standard by the US FDA. 

Medical device software validation companies follow the general principles of software validation documentation here

Dedicated Teams

Let our dedicated professionals with years of experience and expertise fill in any gaps occurring in your employee skillset or requirements with a team-based engagement.

Reasonable Cost

Being a custom healthcare software development company helps in developing at a reasonable cost. This is because, with custom development, you only pay for what you need, and we work within your budget.


What Our Valuable Clients Say

Our Latest Articles