Medical Device Analysis and Testing Publications

Check out the latest publications for Medical Device Analysis and Testing .

Latest Publications

  • 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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  • White Paper: Implementing an Effective GLP Program at the Contract Laboratory

    • 6 months ago

    This article from the Journal of GXP Compliance, by Richard C. Wedlich, Director of Quality...

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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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  • White Paper: Extractables and Leachables Case Study

    • 1 year ago

    Any container closure system has the potential to leach unwanted contaminants into a drug product...

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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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  • Short Chain Fatty Acid Analysis

    • 2 years ago

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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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  • Implementing an Effective Provider Qualification Program (published in Journal of GXP Compliance)

    • 3 years ago

    This paper provides useful hands-on guidance regarding the process of provider qualification.

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  • Implementing Quality Agreements at the Contract Laboratory (published in Journal of GXP Compliance)

    • 3 years ago

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  • Sample Transmittal Form

    • 3 years ago

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