Medical Device Software Testing & QA

For medical device software, inadequate testing is a risk to patient safety, regulatory approval, and your company’s reputation.

We specialize in comprehensive Testing & QA services tailored to the unique demands of medical devices, ensuring your software meets the highest standards of safety, performance, and compliance. From unit and system testing to verification & validation per IEC 62304, usability testing for IEC 62366, and cybersecurity assessments aligned with FDA guidance, we help you catch issues before they reach patients or regulators.

See how our expert testing & QA services can ensure your medical software is safe, reliable, and ready for commercialization.

SERVICES

Safe, Secure & Reliable Software for Your Regulated Medical Device

Medical devices are critical since they directly impact the health and well-being of patients. Therefore, medical device software testing is an absolute necessity to ensure functional and optimal performance of these devices.

Operating under the leadership of our Director of Quality & Process, our testing & QA teams understand the critical importance of documenting design, coding to a standard, and completing thorough testing across the development lifecycle.

HOW WE CAN HELP

MEDICAL DEVICE SOFTWARE TESTING & QA

Testing medical device software is crucial to ensure the safety and efficacy of the device. Through our quality processes, superior resources, and testing expertise, we’ll assure functionality, reliability, and performance for your medical devices without risking your product commercialization success.

Whether it’s helping a client fill an immediate testing need or supporting our client across the entire development process – Syncro Medical’s engineers are ready, and we can scale our team to meet your medical device software testing needs. We routinely help our clients with the following testing & QA needs:

Sprint Testing

Protocol Creation

Verification Planning

Test Execution

Automated Software Testing

WORKING WITH OUR TESTING & QA TEAM

Our experts will develop a strategic medical device software testing plan to achieve your development goals.

AUTOMATED SOFTWARE TESTING & MEDICAL DEVICES

Automating medical device software testing can be a valuable component of the development process, helping to ensure that the software is reliable, compliant, and safe for use in healthcare settings. However, it should be used in conjunction with other testing methodologies to provide a comprehensive quality assurance approach.

Our testing & QA team is available to answer any questions you may have about incorporating automated software testing into your development process.

Speak with an Expert

DEVELOPMENT EXPERTISE

We support our clients at every stage of the medical device software design and development process

Learn more about how we help our clients accelerate software R&D for their market-leading devices.

Requirements Analysis

SW Proof-of-Concept

Architecture

SW Prototyping

UX/UI Design

SW Implementation

Testing & QA