Regulatory services for advice and EU design dossier preparation for CE Marking

  • April 1, 2019
  • Posted by: AXSource
  • Categories:
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Client Type: Medical Device, CE Marking

Jurisdiction(s): EU

Services Provided: Classified medical device for CE marking.Reviewed project gaps, source files, data, documents, certifications, procedures, facility information to ascertain corrective actions. Prepared response with root cause and timeline.