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PJL27 replied to the topic "Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical" – 6 days, 22 hours ago
These cases highlight the importance of keeping up-to-date with newer regulations. As more research is done, certain things are found to be harmful or dangerous. The FDA is always updating their policies. Additionally, many small changes to a device after… Read more»