Juergen (Kraemer) Mehring
Freelancer
Experience
Freelancer
Mehring Consulting
- Senior Consultant Regulatory Affairs; Medical Devices
- Certified Lead-Auditor EN ISO 13485
- Certified Information Security Officer according to ISO/IEC 27001
- Certified Lead-Auditor ISO/IEC 27001
- Trainer
- Approval strategies, national and international, project management
- Classification of medical device; all risk classes of medical devices (active and non active), IVD devices, especially borderline products
- creating development-accompanying and technical documentation for medical devices, editing existing technical documentation
- review and updating of existing quality management documentation or creating new required quality documents
- Assistance during the CE and international approval process for medical devices, including IVD medical devices
- Preparation and review of technical files; compliance with regulatory and legal requirements
- Serious Incident and Filed Safety Corrective Action (Recall) reporting; correspondence with the competent authorities within the EEA
- Implementation of Quality Management System (EN ISO 13485)
- Quality-Remediation
- MDR / IVDR Remediation
- Project- and Risk-Management
- Implementation of UDI-requirements
- on-site seminar according to the individual requirements
- good relationships to notified bodies and competent authorities
Senior Consultant RA/QA
MDSS GmbH
- Educated QM-Auditor
- Assistance during the CE approval process for medical devices, including IVD devices and active implantable devices
- Implementation of Quality Management System (EN ISO 13485)
- Project- and Risk-Management
- Safety officer for medical devices
- Preparation and review of technical files
- Assistance by clinical studies
- Assistance of international medical device manufacturers located outside the EEA regarding the Medical Device Vigilance System (Authorized Representative), for all medical devices, class I, IIa, IIb, III, IVD, AIMD
- Incident and Filed Safety Corrective Action (Recall) reporting; correspondence with the competent authorities within the EEA
HAI-Implantat GmbH
- Assistance with the research and development of dental implants, prosthetic, and a small active prosthetic
- Supplier audits
- Preparation of technical files
- Implementation of Quality Management System (EN ISO 13485)
- Project- and Risk-Management (EN ISO 14971)
- Regulatory Affairs
- Safety officer for medical devices
Centre for Biomedical Engineering
Coordination and execution of different R&D projects
Improvement for humidity sensors
Wireless foot-switch with Bluetooth
Small reverse osmosis system
Different monitoring and therapy systems
Project Management
Risk- and Quality Management
Regulatory affairs, active and non-active products
Clinical studies
Technical consulting
Usability-Engineering
ABB Automation Products GmbH / FAN GmbH
- Final Thesis: “Investigation of compensation options for the pressure broadening effect in an NDIR spectrometer” (Grade 1.0)
Student assistant at the laboratory for biomedical engineering
University of Applied Sciences Muenster
- R&D project: Optimization of an infrared spectroscopy device
ABB Automation Products GmbH
- Internship: Isotope selective infrared spectroscopy for respiratory detection
Krupp Polysius AG
- Internship: metal-processing industry
Industry Experience
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Experienced in Healthcare, Manufacturing, and Education.
Business Area Experience
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Experienced in Research and Development, Product Development, Project Management, and Quality Assurance.
Languages
Education
University of Applied Sciences Muenster
Münster, Germany
Certifications & licenses
Certified Information Security Officer According To ISO/IEC 27001
Certified Lead-Auditor EN ISO 13485
Certified Lead-Auditor ISO/IEC 27001
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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