Software Quality Assurance (SQA)


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.

SQA Highlights

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.

Quality Assurance in Detail


Comprehensive verification and validation to ensure your software complies with all regulatory requirements.

SW Testing

Testing services spanning all levels, from modular units to integrated system testing.

SW Documentation & Control

Meticulous management of documentation, ensuring full traceability and compliance throughout the software development lifecycle.

DHF for Software

Design file for health device ensures software is user-friendly and meets regulation healthcare needs.

NPS Validation

Validation of non-product software tools involved in development and quality processes.

Templates & Forms

Standardized documentation tools for streamlined SQA process management.

Internal Software Audits

Rigorous audits assessing software quality and compliance with internal and regulatory standards.

Project Assessments

Evaluating projects for compliance and alignment with regulatory expectations.

Gap Analysis

Identifying and addressing gaps in SQA processes.

SDLC Training

Training programs on the Software Development Life Cycle to maintain compliance.

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