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.
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.
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.
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.
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.
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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