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Software Verification and Validation (V&V) is a critical requirement mandated by the FDA and CE for all software integrated within medical devices or standalone medical devices. At MedDev Soft, our expertise ensures thorough V&V activities across a range of systems, guaranteeing compliance and reliability.
Regulatory Alignment
Aligning V&V practices with FDA and CE requirements, we ensure your software in medical devices meets all regulatory standards.
Documentation Development
Our team develops comprehensive documentation, customizing each element to meet your specific needs and regulatory requirements.
Testing and Qualification
Through detailed testing and qualification processes, we guarantee your software operates reliably, adhering to the highest compliance standards.
Comprehensive Documentation
From Software Requirements Specification (SRS) to Software Test Report (STR), we provide comprehensive documentation, ensuring every step of the V&V process is clearly defined and recorded for regulatory scrutiny and future reference.
At MedDev Soft, we are committed to ensuring that your medical software is verified and validated to meet stringent regulatory standards, guaranteeing reliability and compliance. Our approach integrates comprehensive documentation and rigorous testing to provide you with confidence in your software’s performance and regulatory adherence.
Ensure your medical software’s verification and validation is in expert hands with MedDev Soft. Contact us to navigate the complexities of V&V with confidence.
Define the correct process of software life cycle and the required deliverables.
Define potential hazards situations caused by software failure, misuse, cybersecurity, and defining the controls.
We craft detailed specifications that outline the functionality and constraints of your software.
Our architecture design documents depict the software architecture, ensuring it meets the specified requirements, including cybersecurity threat modeling.
Our design documents depict the software design, ensuring it meets the specified requirements, architecture, and fulfills risk controls.
We develop comprehensive test plans that outline the objectives, resources, schedules, and activities involved in testing.
Each test case is meticulously described to guide the testing process and ensure coverage.
Post-testing, we compile reports that detail the results and confirm the software's performance.
We document OTS software, ensuring it's suitable for its intended use in a regulated environment.
Validation activities extend to non-product software, confirming its efficacy in supporting medical device processes.
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