ID1050
Safety Connected Devices
Senior Specialist MSc. EE. (DTU)
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Medical Device and IVD compliance
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Risk analysis, FMEA, FMECA
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Device safety and security standard specialist
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EMC design/test at board & system level. EMC standards & compliance.
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Signal analysis / processing
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RFID, NFC
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Analog & digital filters
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Communication and network solutions, RS232/RS485/RS422, USB, Ethernet, I2C, SPI, CAN
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Wireless solutions incl WiFi, Bluetooth, BLE. RED compliance
Key results
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.
Software/Standards
Extensive knowledge in:
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UL2900-1 and UL2900-2-1
[Security for network connected devices] -
AAMI TIR57
[Medical device security – risk management] -
IEC61010, IEC62368
[Device safety] -
IEC60601
[Safety / Medical Device] -
ISO14971, Risk analysis
[Risk management, FMEA, FMECA]
Personal Characteristics
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.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com