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Strategy 2 Market |
In the design of medical devices, design controls are not necessarily the same as a product development process. A quality management system requires that a process and controls be in place and be documented. Its intent is to guarantee that product development is documented for traceability and that products are made in a consistent manner. For example, a standard such as ISO 13485:2003 requires that a medical device manufacturer establish… Continue reading
Designing new products for Manufacturing and Assembly has always been a challenge. Typically, Manufacturing Experts are added to a Project Team AFTER the basic product configuration has been established. The manufacturing people are then charged with building the new product at the target price. This can be very difficult as the product concept configuration often dictates the use of certain manufacturing processes. For example, one product configuration may require the… Continue reading
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