Medical Device

At Medicologic we take great pride in providing top-class consultants to the Medical Device industry. We have shaped a range of services to fit the needs of our clients and accommodate most potential skills and flexibility needs.

Our services within Medical Device:


With our in-housing service you get full controll of budget, hour-usage and planning tasks with our consultant being present at your office on a everyday-basis.

MDR- & IVDR-Transition

At Medicologic we are ready and able to assist our clients through the new Regulation, and our consultants are both experienced and highly skilled within MDR and IVDR.

Try & Hire

Our experiences in recruiting and matching consultants with our clients’ needs and projects have tought us key insights in recruitment, for the benefit of our clients.

Our consultants within Medical Device:

Senior QA Auditor and QA Lead Expert (ID1040)


  • Quality management & Management representative.
  • PRRC (MDR) & EU authorized rep.
  • Lead auditor (+400), Internal & Suppliers, ISO9001, 13485, MDSAP, MDR. TGA, 21CFR820, CMDCAS, QMS optimization.
    Supplier control and qualifications (SQM & SCAR).

Toxicology and Biosafety (ID1001)


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

Clinical Evaluation and Biosafety (ID1002)


  • Risk analysis.
  • Safety assessment.
  • Clinical evaluation.
  • Multi-disciplinary project management.
  • Strategic planning and execution.
  • Strategic planning and execution of activities supporting industry board goals.

Senior Clinical Compliance Expert (ID1003)


  • 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.

QA / RA expert, Medical Device (ID1004)


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

Quality Management and Regulatory Affairs (ID1005)


  • 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.

Regulatory Affairs & Quality Management (ID1006)


  • 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.

QA Expert with experience in regulatory affairs (ID1007)


  • 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.

Human Factors Engineering Specialist (ID1010)


  • 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.

Labelling, UDI and Traceability Specialist (ID1011)


  • Unique Device Identification (UDI) strategy and implementation.
  • Strategy and implementation of Labelling processes.
  • Full Traceability for Medical Devices (end to end).
  • Basic UDI-DI strategy and implementation (MDR).

HW/SW and Semiconductor Specialist (ID1012)


  • 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.

Management and change management (ID1016)


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

Senior Consultant Medical Device (ID1018)


  • 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.

Validation Specialist, Techno-logy and Chemestry (ID1019)


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

Qualification and Validation (ID1020)


  • 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 Consultant Audit and Validation (ID1025)


  • 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.

Principal Advisor Medical Device (ID1026)


  • 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 (ID1027)


  • 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.

Principal Advisor Medical Device QA/RA (ID1028)


  • 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.

QMS & Supplier Quality Expert (ID1031)


  • Supplier Management.
  • Quality Management.
  • Audit Management.
  • Trained lead auditor/
    internal auditor.
  • Team/Department management.
  • Management representative.
  • Quality system implementation.

Senior QA & Compliance Expert (ID1033)


  • Audit Process Management.
  • Inspection Readiness.
  • Active & Certified Lead Auditor; external/internal audits.
  • Gap Analyses Expert.
  • Root Cause & Investigations SME.
  • Quality Management | QMS elements.
  • Supplier Quality Management.

Thermoplastic Specialist (ID1035)


  • Specialist in selecting thermoplastic raw materials.
  • Handled more than 2.500 thermoplastic raw materials.
  • Raw materials for Medical Devices.
  • Testing and qualifying raw materials.
  • Co-operates with test laboratories globally.

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