Tag Archive for Supply Chain

Design Change: How Does FDA Define It?

Q: From an FDA viewpoint and your own experience, how would you recommend we define a “design change” in our design control procedures? A: FDA has said that any change to the finished, packaged and labeled device should be considered a design…

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Supplier Audits: Are There Any Alternatives?

Q: We’ve run into an obstacle with our supplier audits. How would you handle suppliers who won’t let you audit their facilities because either you’re not a big enough customer or they say they don’t have the time?A:  First of all, remember…

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