Pre-selected consultants
for Hemocue

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

In this consultant-portal, we have selected a line of consultants with potential interest for the projects and tasks at Hemocue.

Toxicology and Biosafety

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.
    Learn more >>>

Clinical Evaluation and Biosafety (ID1002)


Competences:

  • Risk analysis and safety assessment.
  • Clinical evaluation.
  • Multi-disciplinary project management.
  • Post-Market Clinical Follow-up (PMCF) plan and reports.
  • Strategic planning and execution of activities supporting industry board goals.
    Learn more >>>

Materials and Surface Applications (ID1039)


Competences:

  • Materials selection, and Surface modifications, including supplier assessment, aimed for Medical Device products Class II.
    Regulatory requirements including design controls (ISO13485), risk management (ISO14971), biological testings
    (ISO10993-*) and IEC 60601-1
    Learn more >>>

Senior Clinical Compliance Consultant (ID1062)


Competences:

  • Project management
  • Clinical evaluations
  • Clinical compliance (MDR/IVDR)
  • Clinical trials and GCP
  • Clinical investigations and GCP
  • MedTech R&D development and launch
  • ISO 14155, 13485 and 14791
    Learn more >>>

Senior RA Expert MD and IVD (ID1066)


Competences:

  • Regulatory Affairs Certified (RAC)
  • Certified PR 365: MD-QMS ISO 13485:2016
  • Medical Devices and In Vitro Diagnostics products registrations
  • Vigilance
  • Change Control
    Learn more >>>

QA/RA

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.
    Learn more >>>

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.
    Learn more >>>

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.
    Learn more >>>

Senior Consultant Compliance and Management (ID1030)


Competences:

  • Project Management.
  • Quality Management.
  • Medical Device.
  • People leadership and management.
  • Process mapping.
  • cGMP.
  • Performance Management.
  • Change Management.
    Learn more >>>

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.
    Learn more >>>

Senior Consultant, Medical Device Compliance (ID1048)


Competences:

  • Design Control.
  • Risk Management.
  • CAPA.
  • Design validation.
  • Human Factors / Usability.
  • Requirement Engineering.
  • SAMD/SIMD/MDSW.
  • Customer complaint investigation.
    Learn more >>>

RA/QA Expert, Medical Device (ID1058)


Competences:

  • Quality management, Management representative and Gap Analysis
  • PRRC (MDR) & EU authorized rep.
  • Executive management, strategy
  • Trained Lead auditor; supplier audits, internal audits
  • Risk Management, CAPAs
    Learn more >>>

Senior Chemistry Consultant (ID1060)


Competences:

  • Verification & Validation, Laboratory testing
  • Quality Assurance, Medical Devices
  • Audit Manag., Internal Audits, ISO 13485
  • Nonconformance and CAPA Management
  • HACCP and traceability documentation
    Learn more >>>

Senior Compliance and Audit Consultant (ID1063)


Competences:

  • Quality Management
  • Medical Device QMS and implementation
  • In- and external audit and inspection
  • Audit Management and execution
  • Supplier Quality Management and audit
  • Quality tools, i.e. CAPA, NCR, MR
  • Lead auditor
    Learn more >>>

Senior RA Expert MD and IVD (ID1066)


Competences:

  • Regulatory Affairs Certified (RAC)
  • Certified PR 365: MD-QMS ISO 13485:2016
  • Medical Devices and In Vitro Diagnostics products registrations
  • Vigilance
  • Change Control
    Learn more >>>

Regulatory Affairs

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.
    Learn more >>>

Regulatory Affairs & Project Management (ID1057)


Competences:

  • Project Management, R&D
  • Design Controls, R&D
  • FDA approval process (PMA, De-Novo)
  • Technical/regulatory writing
  • Implants and Biocompatibility
  • Sterile barrier systems incl. sterilization
  • Stability (shelf life) / Transportation
    Learn more >>>

RA/QA Expert, Medical Device (ID1058)


Competences:

  • Quality management, Management representative and Gap Analysis
  • PRRC (MDR) & EU authorized rep.
  • Executive management, strategy
  • Trained Lead auditor; supplier audits, internal audits
  • Risk Management, CAPAs
    Learn more >>>

Senior RA Expert MD and IVD (ID1066)


Competences:

  • Regulatory Affairs Certified (RAC)
  • Certified PR 365: MD-QMS ISO 13485:2016
  • Medical Devices and In Vitro Diagnostics products registrations
  • Vigilance
  • Change Control
    Learn more >>>

Audit

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.
    Learn more >>>

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.
    Learn more >>>

RA/QA Expert, Medical Device (ID1058)


Competences:

  • Quality management, Management representative and Gap Analysis
  • PRRC (MDR) & EU authorized rep.
  • Executive management
  • Strategy
  • Trained Lead auditor; supplier audits, internal audits
  • Risk Management, CAPAs
    Learn more >>>

Senior Chemistry Consultant (ID1060)


Competences:

  • Verification & Validation, Laboratory testing
  • Quality Assurance, Medical Devices
  • Audit Manag., Internal Audits, ISO 13485
  • Nonconformance and CAPA Management
  • HACCP and traceability documentation
    Learn more >>>

Senior Compliance and Audit Consultant (ID1063)


Competences:

  • Quality Management
  • Medical Device QMS and implementation
  • In- and external audit and inspection
  • Audit Management and execution
  • Supplier Quality Management and audit
  • Quality tools, i.e. CAPA, NCR, MR
  • Lead auditor
    Learn more >>>

Validation and Qualification

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.
    Learn more >>>

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.
    Learn more >>>

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.
    Learn more >>>

Senior Qualification & Validation Expert (ID1065)


Competences:

  • CQV packages – URS, CARA, DQ, FAT, SAT, IQ, OQ, PC/PJ/PFV/PV), CV and CM.
  • Risk assessment + FMECA
  • SME in Process Cleaning of multipurpose and dedicated facilites
  • QA and product release.
  • GMP, GdocP
  • Deviation handling
    Learn more >>>

Engineering

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.
    Learn more >>>

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.
    Learn more >>>

Combination Product Developer (ID1024)


Competences:

  • Project Management
  • Medical Device Testing Strategies and Implenentation
  • Management of R&D projects and R&D teams
  • Concept and idea generation
  • Drug-Device combination products
  • Device troubleshooting.
    Learn more >>>

Medical Device R&D Expert (ID1044)


Competences:

  • Systems engineering. Requirements, test and traceability.
  • Design verification, electronics. Test protocols, execution and reporting.
  • Product development. Elaborate hands-on experience (hard- and software).
  • Pharma and automation, hard- and software.
    Learn more >>>

Senior R&D Consultant (ID1064)


Competences:

  • Diagnostics – ‘Point-of-Care’
  • Microfluidics
  • Sensor development and integration
  • Apparatus construction
  • Industrial design
  • Surface chemistry
  • Biochemistry
  • Laser machining (CO2, Excimer)
    Learn more >>>

Data UDI and Labelling

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).
    Learn more >>>

SaMD and Cyber Security

Senior Consultant, Medical Device Compliance (ID1048)


Competences:

  • Design Control.
  • Risk Management.
  • CAPA.
  • Design validation.
  • Human Factors / Usability.
  • Requirement Engineering.
  • SAMD/SIMD/MDSW.
  • Customer complaint investigation.
    Learn more >>>

Senior RA/QA SaMD Specialist (ID1053)


Competences:

  • Medical devices regulatory compliance
  • MDSW/SaMD Life-cycle management
    Regulatory Strategy and Submission
    Digital Therapeutics (DTx)
    AI/ML Enabled Medical Devices
  • Project Management
  • Quality Assurance and Design Assurance
  • Design Control
    Learn more >>>

RA/QA Expert, Medical Device (ID1058)


Competences:

  • Software Validation
  • Quality management, Management representative and Gap Analysis
  • PRRC (MDR) & EU authorized rep.
  • Executive management, strategy
  • Trained Lead auditor; supplier audits, internal audits
  • Risk Management, CAPAs
    Learn more >>>

Senior RA/QA Software Specialist (ID1059)


Competences:

  • Medical devices regulatory compliance (MDR)
  • In vitro devices regulatory compliance (IVDR)
  • Software as a medical device (SAMD)
  • Cyber security
  • Verification and Validation
    Learn more >>>

Project Management

Senior Consultant Project Management (ID1049)

 
Competences:

  • Project and Program Management within Operations and R&D
  • Create overview and transparency in complex projects
  • Broad business understanding
  • Project implementation in Operations
  • Solid knowledge of implementation and maintenance of ERP systems
    Learn more >>>

Medical Device Manufactoring (ID1052)

 
Competences:

  • Medical Device Production Development
  • Project Management
  • Verification, product transfer,
    validation
  • Product management
  • Quality management
  • Risk management
  • MDR
  • Learn more >>>

RA/QA Expert, Medical Device (ID1058)


Competences:

  • Quality management, Management representative and Gap Analysis
  • PRRC (MDR) & EU authorized rep.
  • Executive management, strategy
  • Trained Lead auditor; supplier audits, internal audits
  • Risk Management, CAPAs
    Learn more >>>

Senior RA/QA Software Specialist (ID1059)


Competences:

  • Medical devices regulatory compliance (MDR)
  • In vitro devices regulatory compliance (IVDR)
  • Software as a medical device (SAMD)
  • Cyber security
  • Verification and Validation
    Learn more >>>

Senior Compliance and Audit Consultant (ID1063)


Competences:

  • Quality Management
  • Medical Device QMS and implementation
  • In- and external audit and inspection
  • Audit Management and execution
  • Supplier Quality Management and audit
  • Quality tools, i.e. CAPA, NCR, MR
  • Lead auditor
    Learn more >>>

Contact

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

contact@medicologic.com
LinkedIn-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

Anders Wiberg
CMO / Marketing
(+45) 26 23 71 87
anders.wiberg@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.