Medical Device Compliances and Quality Systems Publications

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

Latest Publications

  • White Paper: Why FDA Needs to Have More Enforcement Over Lab Developed Tests (LDTs)

    • 3 months ago

    In this article, Mary C. Getz, Vice President of Quality in NSF International’s Medical Devices...

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  • White Paper: Analytical Methods Needed for Combination Pharmaceutical/Medical Devices

    • 5 months ago

    While combination pharmaceutical/medical devices have the potential to fulfill major unmet medical needs, they also...

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

    • 8 months ago

    To assist companies which are currently or in the future intend to place medical devices...

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

    • 10 months ago

    The majority of medical devices in the U.S. are brought to market through the 510(k)...

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

    • 1 year ago

    3D printing is beginning to impact almost every phase of manufacturing, regardless of product type,...

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

    • 1 year ago

    According to NSF International’s Alan Perlman, the creation of balanced, transparent, consensus-based GMP standards that...

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

    • 2 years ago

    Since the first combination products came under the Food & Drug Administration’s purview over 40...

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  • Clinical & Regulatory Strategy and Submissions Consulting

    • 2 years ago

    NSF Health Science Medical Devices’ regulatory team provides a range of specific services to meet...

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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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  • White Paper: Regulatory Overview of Proposed LDT Framework

    • 2 years ago

    In 2014, the U.S. Food & Drug Administration took the first actionable step toward enforcing...

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

    • 2 years ago

    The Food and Drug Administration Safety and Innovation Act (FDASIA) workgroup seeks to create a...

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  • White Paper: New Regulatory Pathway Options for PMA Products

    • 3 years ago

    In 2014, the FDA issued two complementary draft guidance documents related to premarket approval (PMA)...

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