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Tag: eu authorised representative brexit

Home eu authorised representative brexit

The Need of EU Authorized Representatives for Asian Medical Device Manufacturers

By Waqas Imam0 CommentsGeneral
Why is there a Need for EU Authorized Representative? Appointing an Authorized Representative is necessary for non-EU-based medical device manufacturers. If a manufacturer does not nominate the Authorized Representative to repent him in Europe, the Notified Body will not issue him the CE certification. Moreover, every manufacture is also required…
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TSQ Asia & Middle East is well positioned for providing support in Medical Device field. We are a European company ISO 13485:2016 Certified extending support with local presence in Middle East and Asia to help business leaders with daily challenges in device Product Development and QA/RA matters.
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  • Home
  • QMS Support
    • ISO Management System
    • Trainings – ISO & Regulatory Affairs (Medical & Pharmaceuticals)
    • MDSAP – Medical Device Single Audit Program
    • Usability & HFE
    • VMP IQ/OQ/PQ Validation
  • Regulatory Support
    • MDR 2017/745
    • Medical Devices EU Compliance & Regulatory Support
    • EU Design Approval Support
    • Medical Devices Registration to South America
  • CE MARK
  • EU Auth. Rep.
  • UKCA
  • Contact US