Are you Ready for a Transformation?

Medical Device Software Validation For 100% Compliance

Our medical device software verification process evaluates your healthcare devices seamlessly, ensuring data integrity and enhancing compliance.


Paperless Medical Device Software Validation

Medical device software verification and validation processes are complex and time-taking. The verification should be documented before releasing the healthcare device in the market to conform with regulatory requirements such as FDA, EU, etc. Continued win in the medical device market needs continuous adherence to applicable regulations and international standards (ISO 13485, ISO 14791, 21 CFR 820, and 21 CFR Part 11). Paper-based documentation hinders innovation, causes compliance issues, and puts a question mark on your credibility.

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

Folio3 medical device software validation is done by professionals through innovation, superior resources, and testing expertise. This means we’ll assure the top performance of your medical device software so that you can release your device in the market with confidence.

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

And this is not it. Our medical device software validation services are tailored to your needs to launch your device in the market quickly with complete compliance and functionality.


benefits we provide

Benefits Of Medical Device Software Verification, Validation, and Compliance

The software validation 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 software validation services come to the rescue. A trustworthy software verification team streamlines and accelerates the process and also increases efficiency. As a medical device manufacturer, you can reap the following benefits from apt medical device software validation:

process we follow

Our Medical Device Software Validation Procedure

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

The Folio3 team performs software V&V using a combination of on-site/off-site resources. Continuous assistance is also provided to prepare other important deliverables of the Software Development Life Cycle (SDLC) and surrounding processes for an efficient risk traceability matrix, seamless software release documentation, and apt software maintenance plan.

Documentation & Architecture Validation

Software requirements are documented in collaboration with the developers using identified client needs and overall system requirements. Software architecture is prepared and validation is performed.

Develop Strategy & Traceability Matrix

Software detailed design is prepared and a strategy is developed to capture SDD. Then the traceability matrix is created according to software requirements to risk mitigations and to verify in its entirety.

Unit Testing & Integration Testing

Unit testing and integration testing are carried out in accordance with the strategy set in collaboration with the software developers and system engineers.

Software Verification & Validation

Protocols are designed according to the identified software requirements and then apt software V&V is done in collaboration with the software developers, software architects, and engineers.

Software Risk Management

Now Software Risk Management is conducted systematically in collaboration with app specialists, software developers, software architects, and other subject matter specialists.

Computer System Validation

Computer Systems Validation (CSV) for tools used during SDLC is conducted according to the strategy set by software developers to ensure accuracy, reliability, and consistent performance.

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 Telemedicine Website Design?

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