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EACH MEDICAL DEVICE NEEDS A
RISK MANAGEMENT PLAN
Scope of the planned Risk Management activities
Criteria for risk acceptability
Assignment of RM responsibilities
Activities for obtaining post-production information
Review of RM activities
Verification activities
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Our Risk Management Services

  • We write your RMP – you provide us with data and information acc. to our RMP checklists
  • We have extensive experience with Risk Management Plan writing.
  • Our clinicians take over the medical part, our technicians take over the design part of the RMP
  • We integrate your RMP into your preexisting Quality Management System
  • We realize DFMEAs and PFMEAs for you
  • Wir conduct FMEA training
  • We are skilled in FMEA moderation

SERVICES