Safety Connected Devices
Senior Specialist MSc. EE. (DTU)
Available for: Part-time, full-time, tasks
Contact us for full CV
Medical Device and IVD compliance
Risk analysis, FMEA, FMECA
Device safety and security standard specialist
EMC design/test at board & system level. EMC standards & compliance.
Signal analysis / processing
Analog & digital filters
Communication and network solutions, RS232/RS485/RS422, USB, Ethernet, I2C, SPI, CAN
Wireless solutions incl WiFi, Bluetooth, BLE. RED compliance
Key IEC61010 / 60610 compliance specialist on numerous IVD and medical device projects.
Decades of experience in Ensuring Radio Emission Directive and FCC radio compliance on various devices, IVD, medical and others.
Assisting on security risk compliance for several network connected medical devices.
Extensive knowledge in:
UL2900-1 and UL2900-2-1
[Security for network connected devices]
[Medical device security – risk management]
[Safety / Medical Device]
ISO14971, Risk analysis
[Risk management, FMEA, FMECA]
Experienced medical and IVD device compliance specialist within the areas HW solutions, technical lead, hardware design, EMC, medical devices, risk analysis, safety, and security.
Has the ability to focus on the important details while still maintaining the technical overview.
A good communicator which can bridge among the various technical disciplines in a project.
Specialty: Medical device development, IEC60601 compliance, risk management.