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Achieving systematic compliance with the Medical Device Directive.

R Lally1

  • 1Amtac Certification Services, Altrincham, UK.

Medical Device Technology
|August 5, 1996
PubMed
Summary

Achieving compliance with the Medical Device Directive is streamlined by adhering to ISO 9000/EN 46000 standards. A robust quality system ensures adherence to global regulatory requirements.

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Area of Science:

  • Medical Device Regulation
  • Quality Management Systems

Background:

  • The Medical Device Directive (MDD) imposes stringent compliance requirements for medical devices.
  • Existing quality management standards offer a framework for meeting these regulatory obligations.

Purpose of the Study:

  • To identify critical factors for successful compliance with the Medical Device Directive.
  • To demonstrate the utility of ISO 9000/EN 46000 in achieving regulatory adherence.

Main Methods:

  • Analysis of key issues pertinent to the Medical Device Directive.
  • Evaluation of ISO 9000/EN 46000 as a compliance framework.

Main Results:

  • Successful compliance hinges on addressing specific issues within the ISO 9000/EN 46000 framework.
  • A quality system built on these standards facilitates compliance with diverse global regulations.

Conclusions:

  • Implementing ISO 9000/EN 46000 is crucial for Medical Device Directive compliance.
  • These quality standards provide a foundation for meeting broader international regulatory demands.

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