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  • Dkonara921 replied to the topic Design Validation in the forum Project Management Process and Medical Device Development 6 years, 6 months ago

    The way I see it is that the design inputs that you write in must meet the needs of the customer because that is the ultimate purpose of this project. You are doing this project to produce something (e.g. a product or service) that will fulfill the needs of the customer, because he/she is the source of your revenue that your business depends on. There are times when the product may be compromised because there are defects made in the manufacturing process that are not intended. For every 10,000 products, there will always be a certain portion of them that do not fulfill customer needs because there are defects within the device that were caused by an error in actually making the product. Obviously, this was not intended by the businesses but there is always imperfection in producing products and it’s impossible for a manufacturing process to produce perfect products continuously. Not every customer’s needs are met because some of them will get products that have defects that are not the result of a mistake made within the project but that is caused by the manufacturing process. The actual desired product was produced by mass production will yield defective products, which is why people return products and file complaints with the company. It’s possible to produce a product that does meet all of the customer’s needs, but it depends on the number of needs that he/she and what those needs are because they could conflict with each other. However, not every customer will be satisfied because of the aforementioned reasons.