Medical Device Testing

Ensure Regulatory Compliance and Successful Launch of Your Medical Device with QualiZeal for Testing and Quality Assurance. 

The integration of digital technology in healthcare poses a unique challenge as it requires balancing the advantages of speed, accuracy, and automation with the responsibilities of consistency, reliability, and mobility. Medical software developers constantly work on striking a balance between innovation and compliance with regulations.

The process of bringing new medical devices to the market is often hindered by strict regulations, making it a complex and time-consuming task. However, outsourcing the testing and quality assurance of medical device software can alleviate the burden on developers and ensure that potentially life-saving devices reach hospitals and patients.

At QualiZeal, Our QA engineering team possesses the necessary qualifications, protocols, and resources to ensure compliance with regulations and the successful launch of new medical devices.

0 +
Medical Device Testing Experts​
0 +
Successful Medical Device Testing Engagements
0 +
Medical Device Testing Accelerators

Maximize your medical device potential with QualiZeal: Elevate quality, Increase revenue

QualiZeal is proud to be an ISO 13485 certified company. Our commitment to quality is reflected in our compliance with regulatory bodies such as the FDA, MDR (EU), and CDSCO (India). 
We have unrivalled expertise in the medical field, especially in HL7, DICOM and HIPAA compliance to ensure that our clients' medical devices meet the highest standards of safety and efficacy. 
We shift the burden of coordinating and implementing these standards within a functioning test regime away from the development team, in addition to the usual risk assessment task before release. In fact,   we deliver on both fronts- innovation, and regulation.


Level up the speed and quality of your medical device testing concurrent with QualiZeal's expert testing services.

At QualiZeal, we always forecast future inadequacies and plan early. As an ISO 13485-certified company, we provide medical device testing services compliant with major regulatory bodies such as the FDA, MDR (EU), and CDSCO (India).

We are experts in HL7, DICOM, and HIPAA regulatory compliance and guidelines. We ensure that your products meet all regulatory requirements, protecting patient privacy and data security. 

We offer comprehensive software verification and validation services as per IEC 62304 to ensure that medical devices are developed to the required quality level. 

Software Architecture Review and Classification

We review the software architecture to ensure that it meets the requirements of the intended use and is designed in a way that is maintainable, testable, and scalable. We also classify the software according to its safety-criticality level. 

Adherence To Coding Standards And Static Analysis

Our software developers follow coding standards to ensure that the code is consistent, maintainable, and free from defects. We use static analysis tools to detect coding errors, vulnerabilities, and potential design flaws. 

International Quality Standards

We adhere to international quality standards, including IEC 62304 for software development, ISO 14971 for risk management, and ISO 62366-1 for usability engineering. These standards guide our software verification and validation services, ensuring your medical device software is safe, effective, and user-friendly. 

Unit testing and Integration Testing

We perform rigorous unit testing and integration testing to ensure that each individual software unit is functioning as intended and that the different software units work correctly together. We test the functionality, performance, and safety of the software. 

System Software Testing

We test the entire software system, including all software components and interfaces, to ensure that it meets the requirements of the intended use and performs as expected. 

COTS/SOUP Validation

We validate any commercial off-the-shelf (COTS) or software of unknown provenance (SOUP) used in the software to ensure that it is suitable for its intended use and does not introduce any safety risks. 


We perform software FMEA (SFMEA) and design FMEA (DFMEA) to identify potential software failures and their effects on the system and end-users. This helps us to identify and prioritize potential failure modes of the system. 

Testing As Per Alarm Standards Guidelines

If the software is used in a medical device that includes alarms, we ensure that it meets the requirements of the alarm standard guidelines (IEC 60601-1-8). We test the software's ability to generate, process, and manage alarms, and ensure that the alarms are accurate and timely. 


Experience uninterrupted excellence - Unlock the full potential of your systems with QualiZeal's comprehensive SRE services! 

Comprehensive Testing Framework

By choosing us as your single-source vendor for all testing needs, you can benefit from a full product life cycle approach. We offer testing services from plausibility and R&D to product development and quality control, ensuring a comprehensive approach to medical device testing. 

Accelerated Time-to-Market

Our ready-to-use test automation frameworks can help you speed up your time-to-market while reducing the time spent on regression testing and data configuration. With our efficient testing methodologies, we can help you bring your medical devices to the market faster and more efficiently.

Cost-Effective Testing Solutions

We understand the importance of keeping costs under control while maintaining multiple testing goals. That’s why we leverage the latest tools, technologies, and robust testing procedures to provide cost-effective solutions without compromising their quality. We help you achieve cost-reduction while testing your devices and meeting regulatory requirements. 


9901 Valley Ranch Pkwy, Suite 2037, Irving, Texas 75063

Phone: +1 469-816-4010

iLabs Centre, Block B, 2nd Floor, Software Unit Layout, Madhapur, Hyderabad, Telangana – 500081


© 2023 QualiZeal. All Rights Reserved.

Designed by Happening

Disclaimer: The contents of this website, such as text, graphics, images, case studies, and other material on the Site (“Content”), are for informational purposes only. You may not sell, modify, reproduce, copy, adapt, display, publicly perform, distribute, or otherwise use the Content in any way for any public or commercial purpose in connection with products or services that are not offered by QualiZeal in any other manner that is likely to confuse consumers, that disparages or discredits QualiZeal or its licensors, that dilutes the strength of QualiZeal’s or its licensor’s property, or that otherwise infringes QualiZeal’s or its licensor’s intellectual property rights. You may not misuse the Content or use the Content on any other application, website, or in a networked computer environment for any purpose.