Best Practices for Easing the Burden of a Medical Device Remediation Program
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Remediation programs at medical device companies are very hard on everyone involved. DHF and manufacturing remediations resulting from government actions (FDA warning letters, EU's non-compliance reports) are the extreme. The proactive efforts needed for many companies to achieve MDD compliance let alone the jump to MDR are no piece of cake either. Remediation often exhausts the team, brings down morale, and leads to much debate over what is "good enough". Let's talk about best practices to enable remediation efforts to be as pain free as possible.
Please come with questions!