Available resources

At Medicologic we take great pride in providing top-class consultants to the medical industry. Our consultants provide knowledge, know-how, and subject matter expertise on a wide range of areas within the medical industry.


Senior Regulatory Affairs Expert (ID:1001)


  • Regulatory toxicology and product safety.
  • Biological Evaluation Report.
  • Clinical Evaluation Report.
  • Medical Writer.
  • Biological Evaluation Plan.
  • Toxicological exposure and safety assessment.

Senior Consultant Medical Device (ID:1002)


  • Risk analysis.
  • Safety assessment.
  • Change management.
  • Strategic planning and execution of activities supporting industry board goals.
  • National and international grant applications.

Senior Consultant Medical Device (ID:1003)


  • Clinical compliance (MDD).
  • Clinical compliance (MDR/IVDR).
  • Clinical trials and GCP.
  • Clinical Evaluations.
  • Expert insight within the healthcare sector.
  • Business innovation on the basis of science and research.

Senior QA/RA Expert (ID:1004)


  • Project management.
  • Quality management.
  • Management Representative.
  • Gap Analyses.
  • Quality systems implementation.
  • Design Control.
  • Design Dossiers and Technical File forCE marking.

Principal Advisor QM/RA (ID:1005)


  • Management/Project Management.
  • In-depth knowledge of Quality Management Systems World Wide (ISO 9001 / 13485, CMDCAS, MDSAP, Taiwan, TGA & 21CFR820).
  • In-depth knowledge of establishing, maintaining and certification of Quality Management Systems.

Senior Consultant RA/QA (ID:1006)


  • Regulatory and QMS under MDR and IVDR.
  • Product conformity assessment, product classification, assessment route strategies.
  • MDD/MDR andIVDD/IVDR transition•Quality management: ISO 9001, ISO 13485, risk management.

Senior Quality Assurance Expert (ID:1007)


  • Project Management.
  • Executive Management, Strategy.
  • Quality Management Systems ISO 9001, ISO 13485.
  • Design Control and MDR transition.
  • Clean Room, Health and Hygiene and ETO-Sterilization.
  • Process-and sterilization validation.

Senior Consultant QA and RA (ID:1008)


  • Project management; Prince2 certified.
  • Design control, requirements, design gates.
  • Verification, production transfer, validation.
  • Quality management.
  • Risk management.
  • Design FMEA.

Human Factors Engineering Specialist (ID:1010)


  • Development of HFE/Usability strategies.
  • Implementation and integration of HFE/Usability discipline in projects and organizations.
  • Development of processes, work tools and templates to improve HFE/Usability execution and integration with Risk.

Senior Consultant MDR (ID:1011)


  • Implementation of regulatory compliance projects throughout the value chain.
  • Unique Device Identification (UDI) strategy and implementation.
  • Basic UDI-DI strategy and implementation (MDR).
  • Strategy and implementation of Labelling processes.

Senior Consultant Regulatory Affairs (ID:1012)


  • Project management, design control.
  • Medical device engineering, extensive HW/SW and semiconductor knowledge.
  • Product conformity assessment, product classification, GAP analysis.
  • Risk assessment analysis.
  • Electronics engineering, embedded systems, digital.

Senior Consultant Medical Device (ID:1013)


  • Medical Device product development processes:
    R&D process design conforming to ISO13485, ISO14971, FDA 820.30 QSR etc.
    Remediation of product documentation.
  • Systems Engineering, requirements and traceability:
    Authoring, management and traceability.

Medical Device R&D Expert (ID:1014)


  • Excellent task force leader with ability to provide clarity in complex and multidisciplinary problems.
  • Product Verification and Validation.
  • Deep understanding of regulatory requirements including design controls (ISO 13485), risk management (ISO 14971) and IEC 60601-1.

Senior Consultant, Principal Advisor (ID:1015)

Extensive knowledge in:

    • Manage drug delivery device Innovation projects.
    • Knowledge in subcutaneous-and needle free injections.
    • Define and scope projects
    • Develop and manage IPR strategy.
    • Create new business models.

Senior Consultant and Principal Advisor (ID:1016)


  • Management.
  • Change Management.
  • Quality Management and
  • Implementation.
  • IT-system for QA.
  • Process optimizing.
  • Process validation.
  • LEAN.

Senior Consultant, Test and Compliance (ID:1018)


  • Management and project management.
  • Design and implementation of QMS.
  • Design Controls and DHF.
  • Testing Strategies and Implementation.
  • Implementation of the V-model.
  • Design verification.
  • Medical Device Files.
  • Risk Management.

Senior QA Validation Engineer (ID:1019)


  • Lead Validation.
  • Senior CQV Engineer.
  • Risk Assessment.
  • Process and Cleaning Validation.
  • QA Validation.
  • Quality Assurance.
  • CAPA and Compliance.
  • Qualification and Validation.

Senior QA Validation Engineer (ID:1020)


  • Qualification and validation (process/method/software).
  • Risk Management.
  • Process validation.
  • Software and Method validation.
  • Equipment qualification.
  • Six Sigma (trained master black belt).
  • Applied statistics.

Senior RA Consultant (ID:1021)


  • Regulatory Affairs Strategies for Medical Devices.
  • Medical Device Classification.
  • Technical File compilation for EU
  • MDR certification.
  • Clinical Evaluation Plansand Clinical Evaluation Reports.
  • Project Management.

Senior Consultant – R&D Engineering (ID:1022)


  • Syringes, injectors, pumps, IVD and monitoring systems.
    Mechanics, electronics, software and connectivity
  • Design Control: MDR, ISO 13485, 21 CFR820.30
  • Risk analysis: ISO14971
  • FMEA-Experience with Root Caus

Senior consultant, Medical Device (ID:1023)


  • Engineering projects related to Medical Device Industry.
  • Project management, planning and implementation.
  • Compliance (Pharmaceutical and medical device business).
  • Vendor & contract management.
  • Data and trend analysis.

Combination Product Developer (ID:1024)


  • Medical Device product development from idea and business case to volume production.
  • Medical Device Testing Strategies and Implementation.
  • Management of R&D projects and R&D teams.
  • Concept and idea generation.

Senior Consultant Audit and Validation (ID:1025)


  • Qualified Lead auditor with notified body experience for:
  • Medical Device Regulation 2017/745 (MDR).
  • MDSAP.
  • Medical Device Directive 93/42/EEC.
  • ISO 13485:2016.
  • ISO 9001:2015.

Senior Consultant and Principal Advisor (ID:1026)


  • In vitro diagnostics and medical device regulations.
  • QMS management – ISO13485, 21 CFR part820.
  • MDSAP regulations.
  • Vigilance reporting and case handling.
  • Post market surveillance.
  • GMP and quality.

Senior Product Development Engineer (ID:1027)


  • Injection moulding.
  • 2D and 3D part and assembly documentation.
  • Design control.
  • Research and Development.
  • Validation, testing and packaging.
  • Test setup and test planing.
  • Project leading.

Consultant and Principal Advisor QA/RA (ID:1028)


  • ISO13485 Medical device lead auditor.
  • QMS management: ISO13485, FDA 21 CFR part 820 and In vitro diagnostics and medical device regulations (MDR/IVDR).
  • GMP and Quality Assurance (QA).
  • CAPA and non-conformance handling.
  • Process-and test method validation.
  • Risk management.

Know-how, skills and mindset


At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.

Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.

Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.

We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.

The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.


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