Restoring Compliance Under an FDA Consent Decree
How TESCON Helped a MedTech Manufacturer Lift a Permanent Injunction Client: Mid-sized Medical Device Manufacturer Challenge: Facing a permanent injunction and consent decree due to systemic QMS failures and a backlog of 50+ unresolved product failure modes. The Challenge A medical device manufacturer found themselves under a federal consent decree after repeated FDA inspections revealed […]
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