Quality Assurance and Regulatory Affairs


Project Manager Medical Devices

Medical Device Test and Compliance
Available for: Full-time, part-time, tasks

Contact us for full CV


  • ..Management and project management

  • CEO experience in start up

  • Medical Marketing and product launches.

  • Design Controls and DHF.

  • Design and implementation of QMS.

  • Testing Strategies and Implementation.

  • Implementation of the V-model.

  • Design verification – Test protocols/test reports.

  • Medical Device Files.

  • Risk Management.

  • Post Market Surveillance (PMS) and Vigilance.

  • Experienced auditor.

  • Management Representative.

  • Qualified Person.

Key results

  • Antia Therapeutics AG (CEO/Project Manager):
     – Market introduction and sales of Easyx Liquid Embolic.
     – Clinical Studies (Class IIB and Class III).
     – Setting up supply chain.
     – Setting up distribution.
     – CE-Mark Class IIB.
     – ISO 13485:2012 à 2016 certification.

  • Prior to that multiple medical device product launches.

  • Implementation of QMS and ISO 134845:2016 certification at RD-Support.

  • Implementation of QMS at Optoceutics and Measurelet.


Extensive knowledge in:

  • MDR 2017/745, IVDR 2017/746
    [Medical Device & In Vitro Diagnostic Directive]

  • ISO13485:2016 [Medical Device QMS]

  • EN ISO 14971:2019 [Risk Management]

  • EN ISO 19011:2018 [Internal Audit]

  • MEDDEV 2.12-1 rev 8 [Vigilance]

  • MEDDEV 2.7/1 revision 4 [Clinical Evaluation]

Personal Characteristics

He believes in practical solutions that works for people.
He has hands on experience in all aspects of startups and large medical device companies including extended Regulatory and Quality experience.
He can do the job himself as well as teach and coach.
He is an excellent cook and spend his free time mountain biking close to the summerhouse where he is also working on projects.
He is married for a lifetime and has two daughters.


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