Medical Device Compliance


QA/RA Specialist and Lead Auditor

Principal Advisor Medical Device Compliance
Available for: Part-time, full-time, tasks

Contact us for full CV


  • Management / Project Management

  • In-depth knowledge of Quality Management Systems World Wide (ISO 9001 / 13485, CMDR, MDSAP, 1CFR820)

  • Design Control and DHF /DHR

  • In-depth knowledge of establishing, maintaining and certification of Quality Management Systems

  • +25 years auditing experience within Quality Management Systems according to MDD 93/42/EEC, IVDD 98/79/EEC & MDR

  • Recognized Auditor / CE specialist for GMED – France and TÜV SÜD – Italy

  • Internal audit, 2’part (subcontractor) auditing experience

  • Quality Management, Risk Management, Usability, Validation, Clinical Evaluation, Biocompatibility Evaluations, Shelf life/ Stability study, Electrical Safety, EMC, Vigilance, FSCA, CAPA, Process Validation, Sterilization & Clean Room

  • QP (Qualified Person)

  • Management Representative / CTO & Certified Lead Auditor – ISO13485 & CE marking according to MDD 93/42/EEC

  • Training

Key results

  • QA/RA Manager in an international company manufacturing heart / lung machines and disposables for open heart surgery.
  • QA Department manager / project manager in an international company manufacturing electrical – and mechanical equipment for the defence industry.
  • QA/Logistic Manager in a company manufacturing mechanical equipment.
  • Medical Device Manager for an international accredited certification body.
  • As Former CTO & part owner of a Dental Laser equipment company obtained ISO 13485 certification, CE and CFDA approval.
  • Establisher & owner of SEL-Innovation ApS.
  • As independent consultant prepared several medical device companies for ISO 13485 & CE certification.
  • Conducted + 1500 international ISO 13485/ CE audit for several NB & Accredited bodies.
  • Head consultant 2021-2023 for a Danish company manufacturing Urinary implants.


Extensive knowledge in:

  • Medical Device Directive MDD 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC & MDR
  • ISO 13485 / 9001 CMDCAS, Taiwan, TGA etc.
  • EU Harmonized/Internationally recognized standards i.e.
    ISO13485, ISO14971, EN62366, MEDDEV 2.7 / 1, ISO10993 EN60601-X-XX, EN62304, MEDDEV2.12/1.etc.
  • Project Management. International System & CE auditing including Technical File review.

Personal Characteristics

He has a pragmatic and constructive approach and believes that results are best achieved in a straightforward open-minded dialogue between the parties.

He spends his spare time with the family in the summer house and on sports (golf, mountain biking and skiing). He is also interested in literature and music.


Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05