Medical Device Regulatory Support

Check out the latest publications for Medical Device Regulatory Support.

Latest Publications

  • Regulatory Overview of Proposed LDT Framework

    • 2 days ago

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  • EU Medical Devices Auditing

    • 1 month ago

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  • FDASIA Health IT Report and Public Workshop (published in RAPS Regulatory Focus)

    • 4 months ago

    View PDF


  • EU Medical Devices QP Training Brochure

    • 5 months ago

    View PDF


  • White Paper: New Regulatory Pathway Options for PMA Products

    • 6 months ago

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  • Regulatory Strategy for Drug-Device Combinations

    • 6 months ago

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  • Regulatory Developments in the EU, USA and Australia

    • 6 months ago

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  • Focus on Detecting Extractables and Leachables in Drug Products to Improve Patient Safety and Avoid

    • 11 months ago

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  • Regulatory Developments in the EU, USA and Australia

    • 1 year ago

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  • Regulatory Strategy for Drug-Device Combinations

    • 1 year ago

    View PDF


  • QP in New EQ Regs

    • 1 year ago

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