Meet us at Renaissance Schaumburg Hotel, Chicago, IL
We’re excited to be part of the American Medical Device Summit 2025, bringing our expertise in wearable medical devices, R&D, robotics, AI, and regulatory strategies to the forefront. Qualitest will showcase how we help organizations accelerate innovation, ensure compliance, and deliver safer, smarter medical devices to market.
Our Capabilities
Qualitest helps MedTech leaders deliver safe, compliant, and future-ready devices. We bring proven expertise in FDA, EU MDR, ISO 14971, and CFR Part 820, with a strong track record in 510k submissions. Our assurance framework spans Business Assurance, IT Assurance, and Regulatory and Quality Assurance, giving MedTech organizations confidence across every layer of product development and delivery.
Our teams understand devices and workflows end-to-end, from radiology and dialysis to heart monitoring and optometry. We ensure precision through design verification, validation, system integration, and full traceability. With our generative AI-powered platform, we further accelerate requirement generation, test automation, and traceability across the development lifecycle.
With smart automation, HIL/SIL simulation, and cloud-enabled digital health, we accelerate testing while reducing risk. We also embed cybersecurity and resilience into every solution, enabling trusted, next-generation medical devices.
We prioritize digital. Right after human.
Why meet Qualitest at the American Medical Device Summit 2025?
- Built-in quality: See how we design quality into products from the start, rather than only testing at the end.
- Tailored engagements: Explore engagement models customized for the unique quality engineering needs of MedTech platforms.
- Lab expertise: Understand our capabilities in medical device configuration, setup, and maintenance within regulated test lab environments.
- Digital transformation: Learn how we enable cloud migration, infrastructure modernization, and remote patient monitoring solutions.
- Regulatory rigor: Gain insights into our support for design control requirements (verification, validation, DHF, templates, reviews, approvals).
- Compliance assurance: See how we address acceptance activity requirements per 21 CFR Part 820 with robust testing processes and objective evidence.
- Test Automation excellence: Experience our frameworks for automated testing using TOSCA, Python, Squish, Eggplant, Robot Framework, and custom-built tools.
- Domain knowledge: Engage with experts familiar with clinical workflows including imaging, dialysis, heart monitoring, and clinical trials.
