Management Consulting

ID1016

Senior Consultant and Principal Advisor

BSc. ME
Available for: Tasks

Competences

  • Management.
  • Change Management.
  • Quality Management and Implementation.
  • IT-system for QA.
  • Process optimizing.
  • Process validation.
  • LEAN.
  • GMP (Good Manufacturing Process).
  • Project Management.
  • Program Management.
  • Audits/ Inspections (FDA / MDSAP) TGA, CFDA and others.
  • Management Review.

Key results

Management of corporate QA function in both a large Danish and US Medical Device/IVD company Securing compliance and well performed Audits – no major observations.

Aligning QA strategies with Business goals – Training and implementation of SOP’s in global scale MDSAP certification, Legal entity transfer, Preparing for IVDR and MDR.

Standards

Extensive knowledge in:

  • ISO13485 og 14971
    [Medical Device QS and Risk Management]
  • FDA regulation
    [CFR part 820, CFR part 11, UDI]
  • Guideline
    [ICH Q7, Q9 and Q10, GAMP 5, GHTF Process validation]

Personal Characteristics

He is a pragmatic and straight forward person that believes in an open and honest dialogue, he enjoys working with others.

Has many years hands-on experience in implementation and integration of management systems and LEAN.

Spends his free time with family, boating, skiing, diving, kiting and running.

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