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
