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Design control--the ultimate protection?

I R Hendra1

  • 1Bureau Veritas Quality International Ltd., London, United Kingdom.

Medical Device Technology
|March 10, 1991
PubMed
Summary
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Medical device manufacturers benefit from quality systems, adhering to US FDA GMP and UK

Area of Science:

  • Medical device manufacturing
  • Quality systems
  • Regulatory compliance

Background:

  • Medical device manufacturers in the US and UK have increasingly adopted quality systems.
  • Regulatory frameworks like US FDA's 21 CFR-820 and UK's BS 5750 aim to ensure device safety and efficacy.
  • Quality systems are crucial for maintaining standards in medical device production.

Purpose of the Study:

  • To examine the design control elements within medical device quality systems.
  • To evaluate the implications of third-party assessments of confidential documentation in the medical device industry.
  • To discuss the benefits and potential concerns related to quality system implementation for medical device manufacturers.

Main Methods:

  • Review of US FDA's Good Manufacturing Practice (GMP) Regulations (21 CFR-820).

Related Experiment Videos

  • Analysis of UK Department of Health's Guides to Good Manufacturing Practice (based on BS 5750: Part I).
  • Examination of design control aspects within established quality management systems.

    • Main Results:

    • Both US and UK regulations mandate quality systems for safe and effective medical device manufacturing.
    • Design controls are a critical component of these quality systems.
    • The article raises questions about the security and appropriateness of third-party review of proprietary design information.

    Conclusions:

    • Adherence to quality systems, including design controls, is essential for medical device manufacturers.
    • Understanding regulatory requirements from bodies like the FDA and UK Department of Health is vital.
    • The industry should carefully consider the risks and benefits associated with third-party assessments of confidential design documentation.