Available resources

Competences:

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

Competences:

• Risk analysis.
• Safety assessment.
• Change management.
• Strategic planning and execution of activities supporting industry board goals.
• National and international grant applications.

Competences:

• Project management.
• Quality management.
• Management Representative.
• Gap Analyses.
• Quality systems implementation.
• Design Control.
• Design Dossiers and Technical File forCE marking.

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.

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.

Competences:

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

Competences:

• Implementation of regulatory compliance projects throughout the value chain.
• Unique Device Identification (UDI) strategy and implementation.
• Basic UDI-DI strategy and implementation (MDR).
• Strategy and implementation of Labelling processes.

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.

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.

Extensive knowledge in:

• 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.

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.

Competences:

• Lead Validation.
• Senior CQV Engineer.
• Risk Assessment.
• Process and Cleaning Validation.
• QA Validation.
• Quality Assurance.
• CAPA and Compliance.
• Qualification and Validation.

Competences:

• Regulatory Affairs Strategies for Medical Devices.
• Medical Device Classification.
• Technical File compilation for EU
• MDR certification.
• Clinical Evaluation Plansand Clinical Evaluation Reports.
• Project Management.

Competences:

• Syringes, injectors, pumps, IVD and monitoring systems.
  Mechanics, electronics, software and connectivity
• Design Control: MDR, ISO 13485, 21 CFR820.30
• Risk analysis: ISO14971
• FMEA-Experience with Root Caus

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.

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.

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.

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.