Jürgen Mehring
Freelancer, Senior Consultant Regulatory Affairs / Quality Management; Medical Devices, Lead Auditor EN ISO 13485 & ISO/IEC
Experience
Mar 2024 - Present
1 year 5 monthsRied im Innkreis, Austria
Regulatory Consultancy
IVDR Company
- During new medical device (IVD) development, special focus on AI topics
- International Registration of the medical devices (IVD)
- General consulting regarding EU and international medical device compliance
- IVDR compliant documentation
- Labeling, UDI requirements
- Technical documentation
Main relevant standards:
- EU legislation
- International legislation
- EN ISO 14971
- EN ISO 62304
- MDR 2017/746
- Device specific standards
- International AI specific legislations / standards and guidance documents
Mar 2024 - Mar 2025
1 year 1 monthTuttlingen, Germany
Project Lead
IVDR / MDR Company
- Update of QM procedures
- MDR / IVDR remediation
- Labeling, UDI requirements
- CSV (UDI Platform)
- Technical documentation
- CE approval process including device launch
Main relevant standards:
- EN ISO13485
- Device specific standards
- FDA
- MDSAP
- MDR 2017 /745
- IVDR 2017/746
Feb 2024 - Present
1 year 6 monthsFürth, Germany
Project Lead
MDR Company
- Update of QM procedures
- Process validation
- MDR remediation
- Labeling, UDI requirements
- Technical documentation
Main relevant standards:
- EN ISO13485
- Device specific standards
- MDR 2017 /745
Aug 2021 - Jan 2024
2 years 6 monthsMunich, Germany
Regulatory Consultancy
Medical Device Company
- During new medical device development, special focus on AI topics
- CSV
- International Registration of the medical devices
- General consulting regarding EU and international medical device compliance
- MDR remediation
- Labeling, UDI requirements
- Technical documentation
- CE approval process including device launch
Main relevant standards:
- EU legislation
- MDSAP
- International legislation
- EN ISO 14971
- EN ISO 62304
- MDR 2017/745
- Device specific standards
- International AI specific legislations / standards and guidance documents
Jan 2021 - Dec 2024
4 yearsSolingen, Germany
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IVD Company
- Update of QM procedures
- Process validation
- MDR / IVDR remediation
- Update Technical Documentation
- CE approval process including device launch
Main relevant standards:
- EN ISO13485
- Device specific standards
- MDR 2017/745
- IVD 2017/746
- EN ISO 14971
Mar 2020 - Dec 2022
2 years 10 monthsBamberg, Germany
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Medical Device Company
- Update of QM procedures
- UDI compliance EU
- Label-Change process
- Implementation of UDI procedures
- Supplier qualification (UDI)
Main relevant standards:
- EN ISO13485
- Device specific standards
- FDA
- MDR 2017 /745
Mar 2019 - Dec 2022
3 years 10 monthsTuttlingen, Germany
Project Lead
Medical Device Company
- Update of QM procedures
- UDI compliance EU
- Label-Change process
- Implementation of UDI procedures
- Supplier qualification (UDI)
- UDI compliance, international
Main relevant standards:
- EN ISO13485
- Device specific standards
- FDA
- MDSAP
- MDR 2017 /745
- International UDI legislation
Mar 2017 - Jun 2019
2 years 4 monthsHechingen, Germany
Regulatory Responsible
Medical Device Company
- Within new development project (class III implantable medical device)
- CE approval process including device launch
Main relevant standards:
- EN ISO13485
- EU legislation
- International legislation
- Device specific standards
- FDA
- MDR 2017 / 745
Mar 2017 - Mar 2018
1 year 1 monthAhrensburg, Germany
Project Lead
Supplier Company
- Implementation of QM-System according to EN ISO 13485:2016
Main relevant standards:
- EN ISO13485
- EU legislation
Sep 2016 - Dec 2024
8 years 4 monthsMunich, Germany
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Medical Device Company
- Review of technical files
- Updating the technical file
- CE approval process including device launch
- International Registration of the medical devices
- General consulting regarding EU and international medical device compliance
- MDR remediation
- UDI requirements
- Implementation of QM-System according to EN ISO 13485:2016
- Process validation
Main relevant standards:
- EU legislation
- International legislation
- EN ISO 13485
- EN ISO 14971
- EN ISO 10993
- EN ISO 11137
- EN ISO 60601
- MDR 2017/745
- MDSAP
- Device specific standards
Jul 2015 - Jan 2018
2 years 7 monthsBerlin, Germany
Project Lead
Medical Device Company
Headquarter USA.
- Approval strategies for a medical device
- Review of technical files
- Updating the technical file
- General consulting regarding EU and international medical device compliance
Main relevant standards:
- EU legislation
- International legislation
- EN ISO 14971
- ENISO 10993
- EN ISO 11137
Mar 2015 - Dec 2019
4 years 10 monthsNeuwied, Germany
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Medical Device Company
- Review of technical documentation
- GAP analysis
- Updating the technical file
- Preparing STED format
- Technical File Update Project (MDR)
Main relevant standards:
- EU legislation
- EN ISO 14971
- ENISO 10993
- EN ISO 60601
- EN ISO 11137
- MDR 2017 / 745
Dec 2014 - Jul 2016
1 year 8 monthsRastatt, Germany
Project Lead
Medical Device Company
- Update of QM procedures
- Process validation
- UDI compliance
- Label-Change process
- Implementation of UDI procedures
- Supplier qualification (UDI)
- QM-Remediation
Main relevant standards:
- EN ISO13485
- EU legislation
- International FDA legislation
- FDA UDI
- FDA
Jul 2014 - Jul 2015
1 year 1 monthLennestadt, Germany
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SW Medical Device Company
- Implementing a quality management system
- CSV
Main relevant standards:
- EN ISO 13485
- EN ISO 62304
Jul 2014 - Mar 2015
9 monthsDortmund, Germany
Project Lead
IVD Company
- Implementing a quality management system
- Approval strategies for a new medical device (IVD)
- Preparing and review of technical files
- Conducting supplier audits
Main relevant standards:
- EN ISO13485
- EU legislation
- EN ISO 14971
Jul 2013 - Present
12 years 1 monthLeonberg, Germany
Team Lead
Medical Device Company
- Implementing a quality management system
- Process validation
- Approval strategies for new medical devices
- Preparing and review of technical files
- CE approval process
- Conducting internal audits and supplier audits
- Update of QM-System according to EN ISO 13485:2016
- Update of QM-System according to MDR requirements
- Remediation of technical documentation for MDR compliance including device launch
Main relevant standards:
- EN ISO 13485
- EN ISO 14971
- EN ISO 60601
- EN 62366
- MDR 2017/745
Jan 2013 - Jun 2016
3 years 6 monthsWinterbach, Germany
Team Lead
Pharmaceutical Company
Implementing a new business department for medical devices.
- Implementing a quality management system
- Process validation
- Approval strategies for new medical devices
- Preparing and review of technical files
- Conducting supplier audits
Main relevant standards:
- EN ISO 13485
- EN ISO 14971
- EN ISO 10993
- EN ISO 11137
- EN 62366
Sep 2012 - Oct 2012
2 monthsMonheim am Rhein, Germany
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Pharmaceutical Company
- Approval strategies for new medical devices
Main relevant standards:
- EN ISO 62304
- US vs. EU legislation
Jan 2012 - Sep 2023
11 years 9 monthsBorchen, Germany
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Medical Device Company
- Review of technical files
- Approval strategies for new medical devices
- CE approval process
- Conducting internal audits and supplier audits
- Update of QM-System according to EN ISO 13485:2016
- Update of QM-System according to MDR requirements
- Process validation
- Remediation of technical documentation for MDR compliance including device launch
Main relevant standards:
- EN ISO 14971
- ENISO 10993
- EN 62366
- EN ISO 13485
- MDR 2017/745
Jan 2012 - Jun 2021
9 years 6 monthsHanover, Germany
Team Lead
Medical Device Company
- Implementing a quality management system
- Process validation
- Review of technical files
- Approval strategies for new medical devices
- CE approval process including device launch
- Assistance by conducting clinical studies
- Conducting internal audits and supplier audits
- International approval and registration processes
- Update of QM-System according to EN ISO 13485:2016
Main relevant standards:
- EN ISO 13485
- EN ISO 14155
- EN ISO 14971
- EN ISO 11137
- EN 62366
- Singapore
- India
Oct 2011 - Dec 2011
3 monthsReutlingen, Germany
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Medical Device Company
- Approval strategies for new medical devices
- Risk Analysis according to EN ISO 14971
Main relevant standards:
- EU legislation
- EN ISO 14971
Aug 2011 - Nov 2014
3 years 4 monthsMunich, Germany
Project Lead
Medical Device Company
- Implementing a quality management system
- Process validation
- Review of technical files
- CSV
- Approval strategies for new medical devices
- CE approval process including device launch
- International approval and registration processes
Main relevant standards:
- EN ISO 13485
- EN ISO 14971
- ENISO 10993
- EN 62366
- EN ISO 62304
- EN ISO 60601
- FDA (510 k)
- CFDA
May 2011 - Dec 2023
12 years 8 monthsBisingen, Germany
Project Lead
Medical Device Company
- Implementing a quality management system
- Review of technical files
- Approval strategies for new medical devices
- CE approval process
- Conducting internal audits and supplier audits
- Update of QM-System according to EN ISO 13485:2016
- Update of QM-System according to MDR requirements
- Remediation of technical documentation for MDR compliance
Main relevant standards:
- EN ISO 13485
- EN ISO 14971
- EN ISO 10993
- EN 62366
- MDR 2017/745
May 2011 - Dec 2014
3 years 8 monthsJena, Germany
Project Lead
IVD Company
- Implementing a quality management system
- Review of technical files
- Approval strategies for new medical devices
- CE approval process
- Conducting internal audits and supplier audits
- International approval and registration processes
Main relevant standards:
- EN ISO 13485
- EN ISO 14971
- EN ISO 11137
- EN ISO 18113
- FDA
May 2011 - Dec 2011
8 monthsOsnabrück, Germany
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Medical Device Company
- Conducting internal audits and supplier audits
- Review of technical files
- Approval strategies for new medical devices
- CE approval process
Main relevant standards:
- EN ISO 13485
- EN ISO 14971
- ENISO 10993
- EN 62366
Jan 2009 - Dec 2011
3 yearsSpeaker
Delivered seminars and speeches at various events:
- Medical Device Vigilance System according to MEDDEV 2.12.-1 (CMEF China 2009)
- Requirements according to EN ISO 14971 (Summerschool: University Muenster 2011)
- Clinical Study, requirements according to EN ISO 14155 (Summerschool: University Muenster 2011)
Jan 2008 - Dec 2011
4 yearsChina
Project Work and Trade Show Participation
- Several visits in China for project meetings with medical device companies and local notified bodies, supplier meetings, and exhibiting at local trade shows.
Seminar and Workshop Facilitator
Delivered in-house seminars and workshops at various customer sites on topics including:
- Legal requirements for medical device companies: Introduction and borderline discussion to pharmaceuticals
- Legal requirements for medical device companies: Introduction and special focus on medical apps (borderline discussion)
- Workshop: Apps as a medical devices - demarcation problem
- Training: Legal requirements for medical device companies, especially for medical device consultants and safety officers
- Quality Management according to EN ISO 13485
- Risk Management according to EN ISO 14971 – an introduction
- Workshop: Requirements for medical device companies – focus on Risk Management (EN ISO 14971) and Usability (EN 62366)
- Quality Management System: Your friend or foe?
- Clinical studies according EN ISO 14155: Requirements and clinical practice
- Requirements and strategies: Implementing UDI for Medical Devices
- Medical Device Regulation 2017/745: Requirements and Implementation Strategies
- UDI-System: requirement overview and implementation
- “Medizinprodukteberater” according to MPDG
Seminar Facilitator
Academies from Notified Bodies and other training companies
Regularly conducted seminars on behalf of academies from Notified Bodies and other training companies. Topics covered:
- Clinical Studies - approval process as required by medical device directive 93/42/EEC
- Medical Device Legislation: requirement overview, especially risk analysis, biocompatibility, sterilization, clinical and pre-clinical analysis, packaging, labeling, instructions for use, and Harmonized standards (Quality Management / Risk Management and Usability Engineering)
- Medical device Legislation: requirement overview, especially Biocompatibility
- Medical Device Vigilance System: Introduction and Requirements
- Quality Management according to EN ISO 13485 – Requirements and differences to EN ISO 9001
- EN ISO 13485: old version vs. new version
- EN ISO 13485:2016 -implementation-
- Medical Device Master File: content and useful information for preparing
- Legal requirements for medical device companies – a general overview
- Medical Devices Master File: Medical Apps – always class I devices?
- User Manual: content and useful information for preparing
- UDI-System: requirement overview and implementation
- Regulatory Compliance und Change Control Medical Devices
- MEDDEV 2.7.1 rev. 4: What’s new?
- Medical Device Regulation: person responsible for regulatory compliance (qualified person)
- Medical Device Regulation (2017/745)
- “Medizinprodukteberater” according to MPDG
- UDI and EUDAMED
Languages
German
NativeEnglish
IntermediateEducation
Oct 1995 - Dec 1999
University of Applied Sciences Muenster
Dipl.-Ing. · Applied Physics, Biomedical Engineering · Münster, Germany
Aug 1985 - Jun 1995
St. Michael Gymnasium Ahlen
College Preparatory School Diploma · Ahlen, 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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