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mh746 posted a new topic "Lessons from Medtronic’s 2015 Consent Decree – Why Robust Change Control is Critical" – 1 week, 3 days ago
In 2015, Medtronic encountered major regulatory trouble over its SynchroMed II Implantable Infusion Pump. After nearly a decade of inspection findings, the FDA concluded that Medtronic repeatedly failed to address manufacturing violations, including inadequate procedures for identifying and correcting quality… Read more»
