If you’ve received a Warning Letter from the FDA or Notified Body, Regulatory Compliance Associates® Inc. can develop a comprehensive program to address it and any other larger regulatory affairs challenges that may arise with your medical device.

 

We will provide a Project Management Professional (PMP) to lead the program, in addition to engineers with expertise in quality systems and manufacturing engineering to execute the program that coordinates with your resources.

 

Every situation is different and the program’s plan may include aggressive but realistic milestones, as well as supporting tasks, and task dependencies.

 

​Many of our consultants have experience in FDA-regulated industries and have the expertise to assist you with:

 

  • 483 Remediation
  • Warning Letter Remediation
  • Consent Decree Remediation

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