Project
Autobahn
Pre-selected consultants
for Project Autobahn
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 in Project Autobahn.
Project and Commissioning Manager (ID1067)


Competences:
- Project management
- Scope change management
- Risk and opportunities clarification
- Time schedule, cost control and progress reporting.
- FAT, SAT and commissioning
- Qualification of process facility and systems
See mini-CV>>>
Regulatory Environments PM and Coordinator (ID1068)

Competences:
- Project Management
- Planning and Coordinating
- Creating Overview of Complex Flows
- Stakeholder Management
- Process Mapping and Optimization
- Team Leadership & Development
- Resource Planning
- Workshop Facilitation
See mini-CV >>>
Senior Project Manager (ID1069)

Competences:
- Project Management,
- Specification and installation of equipment and facility systems under GMP regulations.
- Stakeholder and client management.
- Lean 6 sigma and hands on experience with analysis systems (JMP (SAS) and Minitab)
See Mini-CV >>>
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.
See mini-CV >>>
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.
See mini-CV >>>
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.
See mini-CV >>>
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.
See mini-CV >>>
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.
See mini-CV >>>
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.
See mini-CV >>>
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.
See mini-CV >>>
Contact
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.