Pre-selected consultants
for Radiometer
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 Radiometer.
Project Management
R&D and Design Control (ID1043)
Competences:
- Program and project management.
- Radiology software, endoscopes, hearing implants, autoinjectors, IVD point of care testing including reagents.
- Mechanics, electronics (IEC 60601 series), software (IEC 62304) and connectivity.
- Design Control and QA: MDR, IVDR, ISO 13485, 21 CFR 820.30.
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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
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Quality Assurance, Regulatory Affairs and Design Control
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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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.
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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.
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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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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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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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Clinical Compliance
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.
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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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Validation and Qualification
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.
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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.
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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
- Learn more >>>
Internal- and sub supplier Audit
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.
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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.
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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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R&D Engineer
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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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.
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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.
Learn more >>>
Senior R&D Consultant (ID1064)
Competences:
- Diagnostics – ‘Point-of-Care’
- Microfluidics
- Sensor development and integration
- Apparatus construction
- Industrial design
- Surface chemistry
- Biochemistry
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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.