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Preclinical Research & Testing for Medical Devices

    https://namsa.com/services/preclinical-research/
    Quantitative angiography may be augmented by additional types of intravascular imaging, including optical coherence tomography (OCT), intravascular ultrasound (IVUS), and …

Cadaver Labs for Medical Device Development - surpassinc.com

    https://surpassinc.com/preclinical-blog/benefits-human-cadaver-labs-medical-device-development/
    Cadaver lab testing is common for cardiovascular medical devices, where evaluating the device in calcified vasculature or heart valves is desirable. For example, a …

Human cadavers to evaluate prototypes of minimally …

    https://pubmed.ncbi.nlm.nih.gov/28946605/
    The cadaver tests provided vital information regarding design and functionality, that failed to emerge during the in-vitro testing. However, experiments are …

Biomechanical Testing of Cadaveric Specimen | Element

    https://www.element.com/nucleus/2019/biomechanical-testing-of-cadaveric-specimens
    The objective of biomechanical testing is to determine how an orthopedic device will behave when implanted into a cadaveric specimen, closely simulating actual function in the human body. The …

The Benefits of Human Cadaver Labs for Medical Device …

    https://www.exponent.com/knowledge/alerts/2015/06/the-benefits-of-human-cadaver-labs-for-medical-d__/
    Studies involving human cadaver tissues can be a valuable resource for companies developing new medical devices. Cadaver labs can involve the use of …

Cadaver Study Testing and Training Facility - surpassinc.com

    https://surpassinc.com/services/cadaverstudies/
    We source only serologically tested specimens from credentialed vendors and can procure human cadavers with previous placed medical devices (stents, heart valves, vascular …

Medical Device Testing Services | 54 Years of …

    https://namsa.com/services/medical-device-testing/
    Established in 1967, NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for reliable, proven testing services. …

FDA publishes guidance on device performance bench …

    https://www.medtechdive.com/news/fda-publishes-guidance-on-device-performance-bench-tests/553523/
    The testing excludes biocompatibility evaluation, reprocessing or sterilization validation, human factors, software verification and validation, and computational …

Medical Devices | SGS - SGSCorp

    https://www.sgs.com/en/service-groups/medical-devices
    In vitro diagnostic devices (IVD) and laboratory equipment; Medical PPE – gloves, masks, surgical gowns; Packaging for medical products; Software; Syringes, medical tubing, …

How to Determine if Your Product is a Medical Device | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
    The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device. Step 1: Determine if your product meets the …



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