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