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Achieving systematic compliance with the Medical Device Directive.
1Amtac Certification Services, Altrincham, UK.
Medical Device Technology
|August 5, 1996
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.
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.