Design Control Engineering
Senior Consultant Regulatory Affairs
Available for: Tasks
Contact us for full CV
- Project management, design control.
- Medical device engineering, extensive HW/SW and semiconductor knowledge.
- Product conformity assessment, product classification, GAP analysis.
- Risk assessment analysis.
- Software engineering: C, Assembler.
- Electronics engineering, embedded systems, digital.
- Signal processing. Reverse engineering documentation.
- Development of high-risk medical systems, dual channel HW/SW safety systems for defibrillators and cardiac pace-makers, algorithms for ventricular fibrillation detection (AED’s).
- Product approvals for medical devices, FDA (510k), TÜV.
- Medical device development and project management within the area of cardiac emergency equipment, intensive care, Holter ECG and patient quality assurance systems verification and validation of high-risk cardiac medical devices.
Extensive knowledge in:
- ISO 62304 software
- ISO 14971 risk management
- ISO 62366 usability
- IEC 60601
- IEC 61010
- IEC 61326
- MDR 2017/745
- IVDR 2017/746
- General specifications
Has a pragmatic and constructive approach and believes that results are best achieved in a straight forward open minded dialogue between the parties.
He has experience in overviewing the entire structure of a company and can integrate himself quickly into new environments.
Spends his spare time out in the nature enjoying wildlife with his black Labrador, always at his side.
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us