Product Overview
Software Quality Assurance
We provide comprehensive Software Quality Assurance (SQA) services to ensure medical device software meets the highest standards of quality, safety, and regulatory compliance throughout the product development lifecycle. Our SQA services are aligned with IEC 62304, ISO 13485, and applicable FDA requirements (including 21 CFR Part 11, where relevant), covering structured verification and validation (V&V), risk-based testing, and lifecycle documentation. We work closely with cross-functional teams to identify and address software defects early, strengthen reliability, and mitigate risks through systematic software risk management, design controls, and phase-gate quality support. Through robust testing strategies and regulatory-compliant documentation, we help manufacturers accelerate time to market while delivering safe, high-performing, and compliant medical device software.
Saraca’s Software Quality Assurance Services include:
– Quality support for software new product development (NPD) and Design History File (DHF) documentation in accordance with IEC 62304
– Software risk assessment and risk management aligned with ISO 14971 and IEC 62304 requirements
– Quality support for software verification and validation (V&V), including manual and automated testing
– Documentation preparation, review, and compliance checks across the software lifecycle
– Quality and compliance support throughout the phase-gate development process
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