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Test Planning

Medical Device Solutions


With decades of innovative collaboration with top tier medical device companies who have standardized their testing needs on our platform approach, Genuen provides specific expertise in end-to-end process-driven solutions for medical device R&D and manufacturing testing. Through certified validation testing and lifetime test systems, we help you uncover initial and long-term details of product performance early, so product team engineers can take action and move forward with data-driven design and test decisions. We provide best practice guidance where teams are concerned about meeting timelines with limited resources, worried about test coverage, or are looking for the peace of mind that comes with collaborating with a team who specializes in mission-critical applications where technology touches humanity.

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Simulation

Closed-loop simulation feedback is essential for providing superior test coverage and identifying anomalies early in the design process. Powerful and flexible Model-in-the-Loop (MIL) and Hardware-in-the-Loop (HIL) testing solutions combined with Genuen's expertise using real-time platforms provide a total solution.

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Development

Medical device manufacturers creating new medical devices and instruments that must adhere to strict regulations, such as IEC 62304, benefit from Genuen's extensive experience in developing test case scenarios and test equipment designed for validation and verification testing. 

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Production

For production testing, you can be confident that Genuen's scalable, automated test solutions will comply with FDA test equipment regulations and will reliably test your medical devices and instruments, so you can ensure that your life-sustaining products are safe for the end user.

Life-Sustaining Testing

Innovative technology solutions for mission-critical medical devices and instruments

requirements

Test Requirement Development for Validation and Verification

Including IEC 62304, 21 CFR 820

HIL Preconfigured Systems

Model-in-the-Loop (MIL) and Hardware-in-the-Loop (HIL) for Medical Devices

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Electrical Mechanical Test Systems

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Medical Instrument Testers

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Embedded Software and System Testing

Tool Qualification Solutions

Tool Qualification

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Data Collection, Management, and Analytics

Translating Aerospace Experience White Paper
WHITE PAPER

Translating Experience from Aerospace to Other Industries


Despite the apparent differences between aerospace and medical device technology, there are significant similarities in designing test equipment to meet functional safety standards for both industries. Learn how Genuen's experience in developing test equipment to meet strict aerospace standards like DO-178 translates to standards and compliance testing in other industries.

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Medical Device Experience


Learn more about our medical device services by checking out these case studies and project examples.

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Creating a Universal Test System Based on LabVIEW

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Meeting Quality Assurance Through Effective Test Strategies

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Software Tool Validation of OTS Medical Software

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EBOOK

Life Cycle and Durability Testing for Medical Devices


Due to the increasingly pervasive nature of software in medical technology, traditional methods of certifying medical devices for public use are no longer sufficient. See what medical device manufacturers can learn from other industries to dramatically improve product quality through testing.

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