R&D and Design Control

MSc Applied Physics
Available for: Part-time, full-time, tasks

Contact us for full CV


Medical Device Development

  • Program and project management
  • Radiology software, endoscopes, hearing implants, autoinjectors, IVD point of care testing including reagents
  • Mechanics, electronics (IEC 60601 series), software (IEC 62304) and connectivity
  • Design Control and QA: MDR, IVDR, ISO 13485, 21 CFR 820.30
  • Risk analysis: ISO 14971 – FMEA
  • Usability (IEC 62366)


  • Technical File and 510(k) preparation, gap analysis
  • QMS optimization & development, writing SOP’s and templates
  • Regulatory strategy
  • Leading R&D organizations
  • Holistic understanding of company value chain

Key results

  • Implementation of radiology management system in Region North

  • Key player in establishment of new endoscopy division and responsible for development of first successful products

  • Key player in integration of cochlear implant division after acquisition and responsible for development and launch of the world’s smallest cochlear implant sound processor

  • Design of regulatory strategy and project management of initial phases for novel autoinjector platform

  • CE marking of 4 point of care diagnostic tests within a year

  • Mentoring and advising startup companies in the medical device space, including the winner of Danish Tech Challenge 2023

  • Industry fellow for DTU X-Tech program

Software and Standards

Extensive knowledge in:

  • ISO13485

  • MDR 2017/745 and IVDR 2017/746
    [Medical Device & In Vitro Diagnostic Regulations]

  • FDA regulation
    [CFR part 820]

Personal Characteristics

Is a seasoned program and project manager with 20+ years of experience in medial device and in vitro diagnostics product development.

Improving people’s lives through new technology he is the main driver and hence he always focuses on bringing the right product with the right quality to the market. He believes that good working relationships at all levels are the key to doing this.

He is a positive person with a pragmatic mindset, excellent communication skills and a taste for leading diverse and international teams.


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