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Our SQA methodology is a testament to our commitment to precision, covering strategic planning, meticulous testing, and rigorous documentation, ensuring readiness for any regulatory audit.
Regulatory Expertise
We apply an in-depth understanding of FDA, CE and worldwide regulations to craft tailored SQA strategies.
Test Planning & Execution
Tailored testing strategies meet the specific needs of all medical device classes.
Documentation & Audit Preparation
We emphasize accuracy in documentation and thorough audit preparation, streamlining the MDR, 510(k) and Pre-Market Approval processes.
Quality Assurance Focus
Our SQA services ensure that every aspect of your software adheres to the highest quality standards, reducing risks and enhancing reliability.
MedDev Soft is dedicated to ensuring your medical software meets and surpasses global regulatory standards, providing a comprehensive approach to SQA that encompasses everything from strategic planning to audit preparation.
Ensure your medical software’s quality and compliance with MedDev Soft. Contact us to leverage our expertise for your regulatory success.
Comprehensive verification and validation to ensure your software complies with all regulatory requirements.
Testing services spanning all levels, from modular units to integrated system testing.
Meticulous management of documentation, ensuring full traceability and compliance throughout the software development lifecycle.
Design file for health device ensures software is user-friendly and meets regulation healthcare needs.
Validation of non-product software tools involved in development and quality processes.
Standardized documentation tools for streamlined SQA process management.
Rigorous audits assessing software quality and compliance with internal and regulatory standards.
Evaluating projects for compliance and alignment with regulatory expectations.
Identifying and addressing gaps in SQA processes.
Training programs on the Software Development Life Cycle to maintain compliance.
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