Medical Device Compliances and Quality Systems Publications

Check out the latest publications for Medical Device Compliances and Quality Systems.

Latest Publications

  • The “Catch-Up” 510(k) - A Submission Often Overlooked (published in RAPS Regulatory Focus)

    • 2 days ago

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  • White Paper: As Manufacturing Moves to 3D Printing Technology, Product Safety Standards Still Apply

    • 3 months ago

    With the advent of 3D printing technology, the way we look at conventional manufacturing may...

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  • White Paper: Retailers and Store Brand Manufacturers Develop Standards Together

    • 4 months ago

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  • White Paper: Combination Products: A 40 Year Regulatory Evolution

    • 12 months ago

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  • Our People

    • 1 year ago

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  • Clinical & Regulatory Strategy and Submissions Consulting

    • 1 year ago

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  • International Services: European Expertise

    • 1 year ago

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  • Quality Systems Compliance, Remediation and Auditing

    • 1 year ago

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  • Regulatory Overview of Proposed LDT Framework

    • 1 year ago

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  • EU Medical Devices Auditing

    • 1 year ago

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

    • 2 years ago

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  • White Paper: New Regulatory Pathway Options for PMA Products

    • 2 years ago

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

    • 2 years ago

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  • Regulatory Developments in the EU, USA and Australia

    • 3 years ago

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  • Regulatory Strategy for Drug-Device Combinations

    • 3 years ago

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