Pre-selected consultants
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 your projects and tasks.
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.
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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.
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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
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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
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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
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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.
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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.
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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.
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Senior Consultant Compliance and Management (ID1030)
Competences:
- Project Management.
- Quality Management.
- Medical Device.
- People leadership and management.
- Process mapping.
- cGMP.
- Performance Management.
- Change Management.
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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.
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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.
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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
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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
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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
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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
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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
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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.
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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
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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.
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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.
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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
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
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.