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Underwriters Laboratories, (UL) has expanded its medical industry services to include Biocompatibility testing. Biocompatibility test reports are part of the regulatory submissions required by the regulatory bodies in the three major medical device markets – United States FDA, Japan MH LW, and European Union Notified Bodies – and support UL's leadership as an end-to-end regulatory and certification services provider for the global medical industry.
Medical and IVD manufacturers can now receive a complete test package through UL's network for all the tests necessary to complete technical file submissions. By working with UL, manufacturers may customize test protocols to minimize testing, samples required and time, while meeting multiple country preferred test methods.
Through its relationships, UL also offers customers access to microbiology, analytical and bioanalytical chemistry, pharmaceutical analysis, and extractable & leachable analysis.
To find out more about UL's biocompatibility and analytical testing services and download your copy of the matrix of requirement for FDA, ISO and MHLW visit: ul.com/hitech/ biocompatibility.
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