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Good People Working on Good Projects with Good Process

Case Study 1: Clinical Evaluation Report (CER)


Situation Mid-sized medical device company required CER to remediate Notified Body findings.
Frestedt Approach
  • Reviewed documentation and conducted systematic literature searches
  • Integrated findings and trained in-house staff to create suitable reports and templates
  • Managed client costs by allocating appropriate expert’s resources for at each level of the CER development process
Results CER completed and staff members trained. Notified Body cleared CER without further remediation. Working relationship established with Frestedt to conduct several other projects in client’s clinical, quality and regulatory departments.