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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 device consultants
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Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training
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Westerwald-Institute
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German consulting group experienced in different licensing procedures of drugs and medicinal products at the national and European level. Website is available in both German and English.
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AQA
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Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
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