Medical Devices Training Publications

Check out the latest publications for Medical Devices Training.

Latest Publications

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

    • 6 months ago

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

    • 8 months ago

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

    • 2 years 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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  • Medical Devices Total Product Lifecycle Solutions

    • 2 years ago

    Learn more about total product lifecycle solutions from NSF Health Sciences Medical Devices Consulting. We...

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  • EU Medical Devices QP Prospectus

    • 2 years ago

    The QA/RA environment is becoming increasingly complex and recent EU legislation advocates placing qualified QA/RA...

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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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  • EU Medical Devices QP Training Brochure

    • 2 years ago

    Learn more about the Qualified Person in Medical Devices training. NSF has implemented the first...

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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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  • Proposal for a Qualified Person in the New European Regulation for Medical Devices

    • 2 years ago

    This article describes the requirement for a Qualified Person (QP) contained in the EU Commission...

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  • EU Medical Devices Overview Brochure

    • 2 years ago

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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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