Design Control Engineering

ID1012

Senior Consultant Regulatory Affairs

BSc. EE
Available for: Tasks

Competences

  • 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.

Key results

  • 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.

Regulations/Standards

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

Personal Characteristics

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.

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