Other links at Business Services > Consulting > Medical and Life Sciences > Regulatory Affairs |
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European Authorized Representative
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Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.
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Medical Devices Consulting
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Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
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PAT toolkit
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Provides information on the FDAa£á?s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative.
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Spherelink FDA Consulting
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Spherelink provides FDA consulting and international trade consulting between Asia and the United States.
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