Medical Devices Training Publications

Check out the latest publications for Medical Devices Training.

Latest Publications

  • White Paper: U.S. FDA System Regulation vs. ISO 13485:2016 Quality Management System Requirements

    • 2 months ago

    Use this tool to ensure your quality management system meets applicable requirements of both ISO...

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  • White Paper: U.S. Medical Device Reporting Code Transition

    • 2 months ago

    This white paper outlines current coding requirements for reporting adverse medical device events to the...

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  • The Do’s and Don’ts of Responding to Deficiencies During FDA Premarket Submission Review

    • 6 months ago

    The majority of medical device companies that submit FDA premarket submissions, including 510(k)s and premarket...

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  • White Paper: 2017 – A Year in Review of Medical Devices

    • 6 months ago

    Regulatory affairs professionals work in a dynamic environment and 2017 was no exception. While the...

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  • White Paper: Combination Products – Inspection Readiness and Outcomes

    • 7 months ago

    Whether you are preparing for a medical device, pharmaceutical or combination product inspection, proper preparation...

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  • MDSAP Portfolio of Services

    • 10 months ago

    The Medical Device Single Audit Program (MDSAP) allows device manufacturers to streamline regulatory compliance for...

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  • White Paper: New EU Medical Device Regulation Adopted April 5th - Impacts Examined

    • 1 year ago

    This white paper examines the new EU medical device regulations and summarizes the perspectives of...

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

    • 2 years 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?

    • 2 years 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)

    • 2 years ago

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

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

    • 3 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

    • 4 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

    • 4 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

    • 4 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

    • 4 years ago

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

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