Impelsys Achieves ISO 13485:2016 Certification for Medical Device Quality Assurance
Impelsys, a global leader in technology solutions, is delighted to announce certification for ISO 13485:2016. This international standard for...
Impelsys is redefining Quality Assurance (QA) by integrating advanced AI capabilities into the testing lifecycle. Through AI-enabled exploratory testing, we go beyond traditional methods to accelerate test execution, reduce manual effort, and uncover high-impact defects faster. Our solutions leverage machine learning, intelligent test automation, and predictive defect analysis to boost accuracy and speed while enabling self-healing test scripts and risk-based testing frameworks for scalable, adaptive QA strategies.
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CASE STUDY
Impelsys’ rigorous functional testing ensured the seamless integration of ICU Connect and CritiXpert with connected medical devices, enabling...
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Web accessibility is a fundamental principle that strives to make the internet inclusive for all. According to the World Health Organization, over a billion people...
We combine the power of AI-driven Quality Assurance with the rigor of globally recognized standards to deliver testing solutions that are both innovative and reliable. Our certifications in ISO 13485:2016 and ISO 9001:2015 Quality Management Systems (QMS) reinforce our commitment to safety, consistency, and regulatory compliance, particularly for medical devices and healthcare technology. By embedding AI into a standards-backed QA framework, we help organizations accelerate testing, reduce risks, and launch high-quality, compliant digital products with confidence.
Our Healthcare QA and Verification & Validation solutions are designed to meet the stringent standards of the medical device and healthcare technology industries, addressing critical needs across the entire product lifecycle—from concept to post-market surveillance. Beyond this, we offer interoperability testing, including Electronic Prior Authorization, Real-Time Benefit Check for FHIR, and more. Using advanced frameworks like Inferno and Crucible, we ensure uninterrupted data exchange, regulatory compliance, and data integrity through test automation and non-functional bulk data testing (Flat FHIR).
Impelsys delivers robust QA solutions designed to meet the evolving demands of digital publishing, ensuring high performance, reliability, and accessibility across platforms. Our end-to-end accessibility testing guarantees compliance with ADA, WCAG, and Section 508 standards, making applications inclusive and user-friendly for all individuals. With a strong commitment to quality and advancement, we help publishers create engaging and accessible digital experiences, empowering audiences worldwide.
Impelsys ensures high-quality digital learning experiences through comprehensive education QA services. Our solutions validate functionality, accessibility, and performance across LMS platforms, e-learning applications, and digital content ecosystems. Our digital content services enhance user engagement by converting existing content into interactive courseware, transforming massive offline content into scalable, digital learning formats that are rigorously tested for usability, responsiveness, and seamless delivery.
A leading US cardiac health organization sought a scalable testing solution for its CME marketplace, providing seamless access to the latest guidelines and diverse eLearning modules for...
A prominent U.S.-based non-profit organization in clinical oncology sought to overcome accessibility challenges to ensure inclusivity for a diverse set of users while empowering...
The client is a prominent global provider of professional information, software solutions, and services spanning multiple industries, such as healthcare, finance, law, and education. They help bridge the gap for students between classroom and clinical practice while...
Software testing is an integral part of an application’s evolution. And it has dramatically transformed over the years. It was manual testing and...
Interoperability in healthcare is pivotal...
In the ever-evolving landscape of software development, Quality Assurance (QA) stands as a cornerstone guaranteeing the robustness and reliability of...
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