Our Consultants

At Medicologic we take great pride in providing top-class consultants to the medical industry. We are partnering up with some of the most skilled consultants in the industry – setting the level of standards and deliveries as high as possible.

We provide freelance consultants within three main categories:

Medical Device, Pharma and Marketing/Business

Medical Device

Toxicology and Biosafety (ID1001)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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.

QA and RA, Medical Device Expert (ID1008)

Competences:

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

Human Factors Engineering Specialist (ID1010)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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.

Medical Device Product devel-opment Processes (ID1013)

Competences:

  • 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 (ID1014)

Competences:

  • 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.

Management and change management (ID1016)

Competences:

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

Senior Consultant Medical Device (ID1018)

Competences:

  • 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)

Competences:

  • 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)

Competences:

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

R&D Program Management and Design Control (ID1022)

Competences:

  • Medical Device Development.
  • Syringes, injectors, pumps, IVD and monitoring systems including reagents, surgical instruments.
  • Mechanics, electronics, software and connectivity.
  • Design Control and QA:MDR, ISO 13485, 21 CFR820.30.

Pharmaceutical and Medical Device Compliance (ID1023)

Competences:

  • 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 (ID1024)

Competences:

  • 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 (ID1025)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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)

Competences:

  • 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.

Senior Consultant Compliance and Management (ID1030)

Competences:

  • Project Management.

  • Quality Management.

  • Medical Device.

  • People leadership and management.

  • Process mapping.

  • cGMP.

  • Performance Management.

  • Change Management.

QMS & Supplier Quality Expert (ID1031)

Competences:

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

Senior QA & Compliance Expert (ID1033)

Competences:

  • 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)

Competences:

  • 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.

Project Manager Medical Devices (ID1036)

Competences:

  • Project and program Management Medical Devices.
  • Implementation of regulatory compliance projects throughout the value chain.
  • Full Traceability for Medical Devices (end to end).
  • Unique Device Identification (UDI) strategy and implementation.

Pharma

Toxicology and Biosafety (ID1001)

Competences:

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

Senior Clinical Compliance Expert (ID1003)

Competences:

  • 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.

Validation Specialist, Techno-logy and Chemestry (ID1019)

Competences:

  • 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)

Competences:

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

Pharmaceutical and Medical Device Compliance (ID1023)

Competences:

  • 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.

Qualified Person (QP), API release (ID1029)

Competences:

  • NC/CAPA Process management.
  • Systematic problem solving (Coaching).
  • Change request process management.
  • Validation Activities (URS, Equipment Qualification, and process Qualification).
  • QP (Batch review and product release).
  • QMS implementation (procedures/templates)

Senior Consultant Compliance and Management (ID1030)

Competences:

  • Project Management.

  • Quality Management.

  • Medical Device.

  • People leadership and management.

  • Process mapping.

  • cGMP.

  • Performance Management.

  • Change Management.

QMS & Supplier Quality Expert (ID1031)

Competences:

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

Senior QA & Compliance Expert (ID1033)

Competences:

  • 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.

Marketing/Business

Medical Device Drug Delivery (ID1015)

Competences:

    • 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.

Strategy & Business Plan Development (ID1032)

Competences:

    • Strategy & business model.
    • Go2Market planning and launch.
    • Market research & analysis.
    • Value Proposition development.
    • Marketing planning and marketing content development.
    • Business plan, budget & business case.

Contact

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

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com

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.