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Related Experiment Videos

Rationalization of standards for medical devices--Part 2.

J J Riordan

    Medical Instrumentation
    |July 1, 1975
    PubMed
    Summary
    This summary is machine-generated.

    Developing new standards, especially for medical devices, is slow and costly. This paper proposes administrative and methodological improvements to streamline standards preparation and enhance their effectiveness.

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    Area of Science:

    • Regulatory Affairs
    • Standards Development
    • Medical Device Regulation

    Background:

    • Current standards development processes are inefficient, characterized by excessive time, cost, and complexity.
    • This inefficiency particularly impacts the preparation of standards for medical devices, instruments, and products.
    • There is a critical need for administrative mechanisms to accelerate standards preparation.

    Purpose of the Study:

    • To analyze administrative, conceptual, and methodological aspects of standards preparation.
    • To identify areas for improvement in the current standards development lifecycle.
    • To propose actionable strategies for enhancing the effectiveness and efficiency of standards.

    Main Methods:

    • Review of existing administrative and procedural frameworks for standards development.

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  • Conceptual analysis of the standards preparation process.
  • Methodological examination of techniques used in standards formulation.
  • Identification of bottlenecks and inefficiencies in the current system.

    • Main Results:

    • Current standards preparation is hindered by significant delays, high costs, and procedural burdens.
    • Administrative, conceptual, and methodological factors contribute to these inefficiencies.
    • Specific areas for procedural and administrative reform have been identified.

    Conclusions:

    • Implementing streamlined administrative mechanisms can expedite standards preparation.
    • Improvements in conceptual and methodological approaches can enhance standards effectiveness.
    • Reforming the standards development process is crucial for sectors like medical devices.