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mb698 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 6 years, 7 months ago
Design control is a formal methodology to conduct the product development activities. It is mandatory to implement such practice when designing and developing products within regulated industries like medical devices. Design control is one of the most important thing in medical device since the design of the product can lower the profit of the company. It causes the poor understanding of the user needs. The product will be very inefficient which would not fulfill the needs of the consumer. Insufficient design control will lead to possibility of non- conformances and non- compliance with regularly expectations. It will cause to lose money and time for insufficient design. It may cause the product to work inefficiently.