Best Practices for Easing the Burden of a Medical Device Remediation Program

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RQ_Device_Love_Live_4-minRemediation 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.

  • How do companies keep up morale and avoid turnover during a remediation?
  • What are ways to minimize team burnout?
  • How do we update the DHF for legacy devices when many of the NPD resources have moved on to other projects or other companies?  The documentation is outdated and the tribal knowledge is gone.
  • How do you make a decision on "good enough" when patching holes in design history files and tech files? 
  • Let's talk about proactive remediation versus warning letter remediation…different levels of intensity and project management.
  • What are some best practices for DHF remediation efforts? 

Please come with questions!