Navigating the Regulatory Maze: Critical Compliance for Catheters & Active Implantable CDMOs
Regulatory compliance is non-negotiable in medical device manufacturing, and for catheters and active implantables, the stakes are higher than ever. These devices, often implanted for months or years, require rigorous validation to ensure safety and efficacy. Contract Development and Manufacturing Organizations (CDMOs) must not only meet these standards but also guide their clients through a...
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