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Design quality--the key to product success
1SULZER Medical Technology Ltd., Winterthur, Switzerland.
Medical Device Technology
|October 6, 1991
Summary
Implementing design controls early in product development is crucial for medical device quality assurance. This proactive approach prevents costly errors and ensures fundamental product quality from the outset.
Area of Science:
- Medical device quality assurance
- Product development engineering
Background:
- Classical quality assurance focused on post-production checks.
- Modern quality assurance emphasizes proactive measures during design.
Purpose of the Study:
- To highlight the critical role of design control in medical device quality.
- To advocate for the implementation of design controls from the product's inception.
Main Methods:
- The article reviews the principles of design control in quality assurance.
- It emphasizes the self-determined nature of design control activities.
Main Results:
- Design control determines not only product characteristics but also fundamental quality.
- Implementing design controls avoids costly errors during the product lifecycle.
Conclusions:
- Medical device manufacturers must integrate design control from the earliest stages.
- This ensures superior product quality and mitigates risks effectively.
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