Software Quality Assurance

Software Quality Assurance (SQA) for medical devices encompasses the systematic processes, procedures, and activities that ensure software meets its intended use and regulatory requirements throughout the entire software development lifecycle.

At Software Quality Guru, our SQA practice is built on decades of combined experience across Class I, II, and III medical devices — from simple wellness apps to life-critical embedded systems.

We align every engagement to IEC 62304 (software lifecycle processes), FDA 21 CFR Part 820 / QMSR, and applicable FDA guidance documents to ensure your software development files are audit-ready.

A robust V&V strategy is the backbone of any compliant medical device software submission. We help clients build V&V plans that scale with software safety classification (Class A, B, or C).

Our V&V services include: Software Requirements Specifications (SRS) review and gap analysis, Software Design Specifications (SDS) traceability mapping, unit/integration/system test planning, and protocol execution support.

We ensure complete bidirectional traceability from user needs through system requirements, software requirements, design outputs, and test results — a common audit finding when missing.

Manual testing alone cannot scale for complex medical device software. We help teams implement compliant test automation frameworks that satisfy IEC 62304 §5.7 and reduce regression burden.

Our automation expertise covers: CI/CD pipeline integration with validation hooks, automated regression suites for embedded and cloud-connected devices, defect management workflow integration (Jira, Azure DevOps, Polarion), and tool qualification per IEC 62304 Annex B.

We document all automation infrastructure to meet 21 CFR Part 11 electronic records requirements when applicable.

FDA inspections, Notified Body audits, and internal QMS audits all scrutinize software documentation. Our team prepares your SQA artifacts to withstand the most rigorous reviews.

Services include: pre-audit gap assessments, corrective action (CAPA) support for software-related findings, 483 response drafting, and mock audit facilitation.

We have supported clients through FDA 510(k) submissions, De Novo requests, PMA supplements, and CE technical files — translating complex software evidence packages into clear, defensible documentation.