Our medical device software verification process evaluates your healthcare devices seamlessly, ensuring data integrity and enhancing compliance.
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.
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:
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.
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.
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 and integration testing are carried out in accordance with the strategy set in collaboration with the software developers and system engineers.
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.
Now Software Risk Management is conducted systematically in collaboration with app specialists, software developers, software architects, and other subject matter specialists.
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.
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The process of medical device software verification and validation includes:
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.
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