Juergen Mehring - Freelancer | FRATCH

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Recommended expert

Ahlen, Germany

Experience

May 2011 - Present

14 years 9 months

Ahlen, Germany

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

Feb 2008 - Apr 2011

3 years 3 months

Hanover, Germany

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

May 2007 - Jan 2008

9 months

Osnabrück, Germany

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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

Jan 2000 - Present

26 years 1 month

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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

Jun 1999 - Dec 1999

7 months

Frankfurt am Main, Germany

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ABB Automation Products GmbH / FAN GmbH

Final Thesis: “Investigation of compensation options for the pressure broadening effect in an NDIR spectrometer” (Grade 1.0)

Oct 1998 - Mar 1999

6 months

Münster, Germany

Student assistant at the laboratory for biomedical engineering

University of Applied Sciences Muenster

R&D project: Optimization of an infrared spectroscopy device

Mar 1998 - Sep 1998

7 months

Frankfurt, Germany

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ABB Automation Products GmbH

Internship: Isotope selective infrared spectroscopy for respiratory detection

Jul 1995 - Sep 1995

3 months

Beckum, Germany

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Krupp Polysius AG

Internship: metal-processing industry

Languages

German

Native

English

Intermediate

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

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