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  • hm243 replied to the topic CAPAs: Proactive vs Reactive in the forum Process Validation and Process Risk 7 years, 11 months ago

    It is good to be proactive and reactive for medical devices. Medical devices may sometimes be used externally, but other times they will be implanted. From a business standpoint it would be more beneficial for a company to be proactive when it comes to medical devices. This will ensure a safer device. As a result of medical devices being used for body applications, it would make more sense to take a proactive approach. This way it will decrease the amount of possible issues that may arise after the device is in use. If the company is unable to perform a proactive method, then the reactive process should be used. The reactive approach gives a summary of all the issues that need to be attended and fixed. It is better to prevent potential problems before and during production then after is it used from a business perspective.