References

Consultancy (Medical safety critical)

Consultant in the CE marking of

  • respiratory exercise system
  • biomarker device on blood samples
  • accessories for MRI/PET scanning
  • hearing aids

Consultancy (Machine safety critical)

Consultant in the CE marking of

  • access control unit to a medical clean area
  • requirement specification of a controller for refrigeration compressors.
  • validation of sending tubes of blood samples through a compressed air system (pneumatic discharge).
  • validation of smoke ventilation panels

Upfront Chromatography (Milk protein separation)

Consultant in the process unit as

  • process unit designer.
  • system tester

with focus on functional safety IEC 61508

ePower Technology (Medical fitness machines)

Consultant in R&D for

  • evaluating software documentation for IEC 62304

according to medical devices IEC 60601

Philips Healthcare (Anaesthesia machines)

Consultant in Quality Assurance for

  • updating technical file for CE marking
  • system tester

according to medical devices IEC 60601

Siemens Flow (Flow measurement device)

Consultant in the product integration as

  • integration test designer
  • system tester

with focus on functional safety IEC 61508

Novo Nordisk (Medical device)

Consultant in the R&D department for insulin pumps as

  • process architect for development methods and tools
  • system test manager
  • software developer of communication protocols

with focus on medical devices IEC 60601