REPLACEMENT OF EXISTING MEDICAL DEVICE COMPLIANT WITH A NEW QMS

                                     

CHALLENGE

  • New EMC and Safety standard effective by December 31, 2018
  • New QMS was introduced
  • Project first mover
    • Risk identification
    • UI risk identification
    • Software compliance
  • Compliance to MDR

 

SOLUTION

  • Evaluation of QMS gap
  • Risk, UI, software workshops
  • Conduct HW and mechanical design
  • Evaluation of gap with software compliance

 

BENEFITS

  • Documentation according to standards
  • Artefacts delivered within agreed time, scope, cost and quality
  • A pragmatic and fast approach
  • QMS tailoring
DIS