Software Development and Quality Assurance for Medical Devices
In QMLogic, we ensure that every line of code contributes to a compliant, reliable, and safe medical device software product. Our approach to software development merges engineering excellence with regulatory-grade quality assurance and continuous integration and delivery (CI/CD) practices.
“True innovation in medical software is about writing confidence into every release.”
Quality Built in Each Lifecy Cycle Phase
Quality in medical device software isn’t a box to check; it’s a discipline embedded into every stage of the product’s lifecycle. From concept to post-market monitoring, we ensure that every process, deliverable, and tool supports compliance and patient safety.
Core Principles of QA in Medical Device Software
Our QA framework ensures that your product meets regulatory expectations and performs safely and effectively throughout its lifecycle.
- Proactive quality per design – every feature and component is architected and integrated to meet safety, performance, and compliance goals.
- Integration in the complete life cycle - QA covers everything from design and development to manufacturing and post-market activities.
- Compliance alignment - we implement quality processes fully harmonized with IEC 62304, IEC 82304, ISO 13485, ISO 14971, and IEC 81001-5-1.
- Automation support – our CI/CD pipelines and QMS integrations help you maintain validation, traceability, and documentation automatically.
“Quality assurance is a foundation for every development iteration.”
Our QA Framework in Practice
Design Control
We establish robust design control processes ensuring that every design input, output, and verification activity aligns with both technical and regulatory expectations.
Risk Management
We apply ISO 14971 principles systematically — identifying, evaluating, and controlling risks across the software lifecycle.
Cybersecurity Integration
We implement IEC 81001-5-1 to integrate security practices directly into your Technical Documentation.
Documentation and Traceability
We help you maintain complete documentation sets, including DHF – Design History File, DMR – Device Master Record, and DHR – Device History Record, ensuring full regulatory traceability and submission or audit readiness.
Supplier and Audit Management
We qualify suppliers, assess infrastructure and development tools, and evaluate SOUP/OTS components used in the product.
Post-Market Surveillance
We monitor device performance, safety, and security after release, helping you stay compliant with regulatory and cybersecurity regulations.
“Regulators trust data, not promises. Our Quality Assurance approach makes your compliance demonstrable.”
Integrating Quality Assurance with CI/CD in Medical Device Software Development
At QMLogic, we connect the precision of regulatory-grade quality assurance with the speed and transparency of modern software engineering. Our goal is to ensure that every CI/CD step not only delivers new functionality but also generates verifiable evidence for compliance and technical documentation.
“Automation in quality makes compliance a natural part of development flow.”
Connecting QA Procedures with CI/CD
Quality assurance in medical device software development extends far beyond testing. It includes full traceability, risk management, verification activities, and creation of technical documentation. By linking QA activities with CI/CD pipelines, we make compliance transparent and reproducible.
We integrate QA processes into CI/CD to achieve:
- Automated execution of verification and validation steps
- Continuous generation of test reports and traceability matrices
- Automated linkage of software requirements to risk control measures
- Seamless synchronization between design, testing, and documentation tools
“Transparency is not a report you write; it’s the system you design.”
Our CI/CD Technology Tool Chain
We support a wide range of modern development and testing ecosystems, ensuring flexibility across different architectures and programming languages.
- Version Control and CI/CD Platforms: GitHub, GitLab, Bitbucket, Azure DevOps
- Programming and Frameworks: Java with Spring Boot, C# with .NET, JavaScript with React, Node.js, and Next.js
- Behavior-Driven Development (BDD): Cucumber (Java/.NET), SpecFlow (.NET), Jest (JavaScript)
- End-to-End Testing: Playwright, Selenium, Appium
- API Testing and Automation: Postman, Newman, REST Assured
- Issue and Requirement Tracking: Jira (R4J) and Azure DevOps Boards
“The tools you use daily can be your strongest compliance allies when configured the right way.”
Automation in Quality Assurance
Automation not only accelerates development, but it also makes quality measurable, repeatable, and auditable. By embedding QA steps into CI/CD, we ensure that every build and deployment provides verifiable proof of compliance.
Our automation principles include:
- An automated set of testing triggered by every commit
- Behavior-driven testing scenarios mapped to system requirements and other design inputs
- Automated generation of traceability reports and test evidence
- Integration with QMS for automatic storage of validation outputs
“Automation turns compliance from an obligation into a continuous assurance process.”
Compliance Meets Transparency
We align software development processes with regulatory requirements such as 21 CFR 820.30 and IEC 62304. Our approach ensures that all artifacts, from requirements to test results, remain fully transparent and traceable.
Our compliance integration covers:
- Requirements traceability from the system level to the software detail level
- Risk management alignment with ISO 14971
- Secure design control and verification under IEC 62304 and IEC 82304
- Automatic evidence creation for Design History File (DHF) and Device Master Record (DMR)
- Support for cybersecurity compliance per IEC 81001-5-1
“Compliance doesn’t slow development; lack of automation does.”