Medical Device Compliances and Quality Systems Publications

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

Latest Publications

  • EU Medical Device Regulations - Are You Prepared for the Impact?

    • 4 months ago

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

    • 5 months ago

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

    • 9 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

    • 9 months ago

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

    • 1 year ago

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  • Clinical & Regulatory Strategy and Submissions Consulting

    • 2 years ago

    Learn about NSF Health Sciences Medical Devices' regulatory team and what services they offer.

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  • International Services: European Expertise

    • 2 years ago

    Learn about NSF Health Sciences Medical Devices' European-based experts and what services they offer.

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  • Quality Systems Compliance, Remediation and Auditing

    • 2 years ago

    Learn more about quality systems compliance, remediation and auditing from NSF Health Sciences Medical Devices...

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  • Regulatory Overview of Proposed LDT Framework

    • 2 years ago

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  • EU Medical Devices Auditing

    • 2 years ago

    NSF Health Sciences Medical Devices team provides a comprehensive range of auditing services to support...

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

    • 2 years ago

    The FDASIA workgroup seeks to create a regulatory framework that can ensure the safety of...

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  • White Paper: New Regulatory Pathway Options for PMA Products

    • 2 years ago

    This article summarizes the key topics addressed in the guidance documents and the implications of...

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

    • 3 years ago

    Well-documented incidents of contaminants leaching from containers and packaging has brought heightened awareness of the...

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