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.

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Medical Device Testing Experts

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Successful Medical Device Testing Engagements

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Medical Device Testing Accelerators

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

We have unrivalled expertise in the medical field, especially in audit responsibilities and HIPAA compliance. 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.

Domain Expertise

QualiZeal has a team of experienced professionals with domain expertise in medical device testing. This means that clients can be assured that their devices are being tested by experts who understand the nuances and complexities of medical device testing and can provide tailored solutions to meet their specific needs.

Accurate and Reliable Results

At QualiZeal, we place a strong emphasis on accuracy and reliability in our testing services. Our state-of-the-art equipment, rigorous testing procedures, and experienced professionals ensure that clients receive accurate and reliable results that they can trust.

Faster Regulatory Compliance

QualiZeal understands the importance of regulatory compliance in the medical device industry. Our expertise and streamlined processes enable us to help clients achieve faster regulatory compliance, reducing the time to market for their devices.

Access to the Latest Equipment

QualiZeal is committed to staying up to date with the latest equipment and technologies in the field of medical device testing. This means that clients have access to the most advanced equipment and testing methods, helping them to achieve optimal results and stay ahead of the competition.

Instant Delivery and Reporting

At QualiZeal, we understand that timing is critical in the medical device industry. That's why we offer instant delivery and reporting of test results, enabling clients to make timely decisions and move quickly to the next stages of the product development process.

Higher Returns on Investment

We save up to 50% of your QA spend. It is all about leveraging the expertise and resources of your partner to provide better ROI on your product - a valuable asset within a healthcare field spontaneously waging a cost versus benefit battle.

SOLUTIONS

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. Experience helps us measure risks and report with actionable counters. We also Examine the results to enable standardization and optimize the testing process. We have extensive expertise in developing testing strategies that meet the demands of regulatory bodies while delivering high-quality results.

We are committed to providing our clients with exceptional services, leveraging our vast knowledge and expertise in medical device testing to help them achieve their goals and surpass expectations. This enables you to bring your medical devices to market faster, generating revenue more quickly and increasing your ROI.

Risk Assessment

Before a medical device can be introduced to the market, it is important to assess the risks associated with its use. QualiZeal offers comprehensive risk assessment services to evaluate the safety and effectiveness of medical devices. This includes identifying potential hazards, determining the severity of harm that could result from those hazards, and assessing the likelihood of harm occurring.

Performance Testing

To ensure that a medical device meets the required standards for performance and reliability, QualiZeal offers a range of performance testing services. This includes evaluating the accuracy of measurements, testing for durability and fatigue, and assessing the stability of materials over time.

Biocompatibility Testing

Medical devices must be biocompatible, meaning they do not cause harm to the body when in contact with tissues or fluids. QualiZeal offers biocompatibility testing services to assess the compatibility of medical devices with biological systems. This includes testing for irritation, sensitization, cytotoxicity, and systemic toxicity.

Usability Testing

To ensure that a medical device is user-friendly and easy to operate, QualiZeal offers usability testing services. This includes assessing the device's ease of use, accuracy, and efficiency, as well as identifying potential user errors and ways to mitigate them.

Regulatory Compliance

QualiZeal's medical device testing services are designed to help clients meet regulatory requirements and obtain necessary certifications. This includes testing in accordance with FDA regulations, ISO standards, and other relevant guidelines. We also offer consulting services to help clients navigate the regulatory landscape and ensure compliance throughout the product development process.

Benefits

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.