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The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy

Introduction Medical device manufacturers have at their fingertips many types of clinical studies to demonstrate product safety and efficacy, one of which is a randomized, controlled pivotal trial. While there are many routes to initiate these types of trials, sponsors requiring such studies would be wise to first consider conducting a small randomized pilot study … Continued

NAMSA Announces New Online Test Selection Tool to Support Global Medical Device Manufacturers

TOLEDO, OHIO – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services is pleased to announce its newly-released online test selection tool, NAMSA Test Navigator, to fully support global medical device manufacturers’ testing requirements.  The Test Navigator was built to provide … Continued

Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval

As any device manufacturer is aware, medical products throughout the globe are regulated according to each device’s targeted country of distribution. While conventional and/or equivalency products typically have a clearcut regulatory pathway, new or improved medical devices are often comprised of time-intensive and sometimes confusing regulatory approval routes. This is especially true for multinational manufacturers … Continued