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Scott replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 2 months ago
A lot of companies and regulators such as BSI, put a lot of time and effort to ensure that the IFUs and graphic labels on the product match. I can see both sides why this is important and why this could potentially be unnecessary. I’ve run into issues with labels in which we couldn’t sell product because the legal entity was mismatched and the location of the manufacturing site was mismatched. It was a somewhat easy but long undertaking to change. Is it completely necessary? Depends who you ask. Does a company stop from making the change? No.