Risik Analysis, FMEA, Validation, Documentation, Consulting/Support for Audits

Our engineering and consulting support is based on the following European and international regulations and guidelines :

  • DIN EN ISO 13485
  • EN ISO 14971
  • EN ISO 15883
  • DIN EN 61000-4-4
  • DIN EN 61010-1
  • DIN EN 61010-2-045
  • Medical Device Directive 93/42 EEC
  • FDA 21 CFR 11
  • GMP Guidelines
  • GAMP 4 / GAMP 5
  • Software-development/SW-validation according to OSI-Modell ISO/IEC 7498
  • available FDA guidances, for computer validation and EU/FDA guidances for inspectors

Measurement records for FMEA documentation

We use our own data acquisition system to record simulated failure behaviour of the test device / test system. Our FMEA documentation is based on these validation records.

Measurement values: (selection)

  • temperature
  • pressure
  • force
  • tourque
  • voltage
  • current
  • load
  • rpm
  • frequencies
  • flow  (gas, fluids)
  • acceleration
  • vibration velocity
  • NVH
  • acoustic pressure
  • recording of interface and control data
  • I²C, RS232, CANbus