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Founder:
Carsten Keller
78567 Emmingen-Liptingen
Contact:
 carsten.keller(at)qm-service.eu
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References / Experience / Skills
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Date / since
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Training: Software Development IEC 62304 (Institut Johner)
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10/2021
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Training: Usability IEC 62366 (3 Days training) (Institut Johner)
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06/2021
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Training: PRRC §15 MDR 2017/745/EU (Institut Johner)
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05/2021
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Training: MDSAP (TÜV Süd) Medical Device Single Audit Program
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10/2019
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Training: Medical Device Forum: New MDR (2 days) (TÜV Süd)
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03/2019
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Training: Internal Auditor 13485:2016 (2 Days Training) (TÜV Süd)
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03/2019
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Training: Medical Device Regulation in detail (MDR) 2017/745/EU (TÜV Süd)
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02/2018
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Training: “new” Medical Device Regulation MDR (reuschlaw)
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09/2017
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Implementation of ETI (Ethical Trade) at the company / successful Inspected by Authority
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09/2017
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Training: EN ISO 13485:2016 (TÜV Süd)
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04/2017
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Training: Processvalidation Medical Devices (IQ, OQ, PQ, (DQ)) (TÜV Süd)
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02/2017
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Training: EN ISO 9001:2016 (TÜV Süd)
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01/2017
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Training: “How to create Motivation” - (BrainSales®)
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04/2016
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Training: UDI Requirements US-FDA (Registrar Corp)
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03/2016
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Advanced Training: “Cleaning and Sterilization” - ISO 17664 / AAMI ST81 (Medical Device Services)
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06/2015
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Training: QWare Riskmanager Rev.7.0 (bayoonet AG)
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06/2015
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Project-Founder & Leader “Validation Reprocessing ISO 17664 / AAMI ST 81” (participation of more than
70 Companies & more than 150.000 Medical Devices)
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05/2015
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Speech Medical Mountains: “Update medical device regulations by PIP scandal”
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05/2015
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Speech Medical Mountains: “Made in Germany”
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04/2015
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Speech from Matthias Berg - “Mach was draus”
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03/2015
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Speech Medical Mountains: Update “New European Ordinance for Medical Devices”
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11/2015
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Training: Reprocessing Medical Devices (Medical Device Services)
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10/2014
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Starting QM-Service.eu
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01/2014
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Training: CMDCAS - Canadian QM-Requirements / Device Registration (TÜV Rheinland)
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11/2013
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Qualification: EOQ (European Organization for Quality) Quality Systems Manager (EOQ , DGQ)
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06/2013
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Active Member of RAPS.org (Regulatory Affairs Professionals Society)
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06/2013
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Training: Medical Electrical Equipment - IEC 60601-1:2005 +A1:2012 (TÜV Süd)
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03/2013
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Training: Project Management / Project Leader (Janus) (1week training)
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03/2013
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Training: Processing Single use sterile Medical Devices (Medical Device Services)
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06/2012
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Training: Registration Medical Devices Eastern Europe (TÜV Süd)
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11/2009
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Training: Registration Medical Devices outside Europe (TÜV Süd)
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06/2009
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Training: Management Systems (EN ISO 13485:2003) for Manufacturers of Medical Devices (TÜV Süd)
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05/2009
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Training: Clinical Evaluation of Medical Devices (EN ISO 14155) (TÜV Süd)
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04/2009
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Training: Registration Medical Devices USA PMA / 510(k) (TÜV Süd)
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07/2008
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Training: QM Requirements for Medical Devices US-FDA 21CFR Part 820 (TÜV Süd)
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07/2008
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Training: Risk Manager (EN ISO 14971) (TÜV Süd)
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03/2008
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Qualification: Quality Manager based on ISO/TS 16949 Automotive Quality Standard (IHK / DGQ)
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01/2006
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Qualification: TQM - Total Quality Management (IHK / DGQ)
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11/2005
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Qualification: Statistically Methods QM (IHK / DGQ)
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10/2005
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Qualification: Quality Management Systems in Application (IHK / DGQ)
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07/2005
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Qualification: Internal Auditor (IHK / DGQ)
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06/2005
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Training: Safety Officer Medical Devices (§30) (HKK)
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04/2005
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Training: German Law of Medical Devices / MDD (TÜV Süd)
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04/2005
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Qualification: Master Craftsman Diploma (IHK)
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02/2005
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Qualification: AEVO - Supervisor for Trainings (HKK)
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03/2003
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Training: Quality Management and Motivation (Steinbeis-Zentrum Qualitäswesen)
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10/1993
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Relevant Jobs
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Company
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Guided FDA-Inspections (overall)
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5
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Current Job(s):
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Professional Freelancer
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QM-Service.eu
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Lehrbeauftragter MDR 2017/745/EU
Associate Lecturer - Medical Device Regulation / CE Marking / Technical Documentation / Device Conformity/
MDR 2017/745/EU
2014 / 2015 / 2016 / 2017 / 2018 / 2019
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Campus Tuttlingen (HFU)
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Job History:
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Director Quality & Regulatory Affairs
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Storz & Bickel GmbH & Co.KG
(01/2019 - 02/2020)
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Director Quality & Regulatory Affairs (global, more than 90 countries),
Director Final Inspection
Director Storage & Logistics (UDI / Barcode Systems)
Safety Officer Medical Devices (§30 MPG)
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LAWTON Medizintechnik
(09/2014 - 12/2018)
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Senior Manager Regulatory Affairs / internal Auditor / Main Responsible for Global Device Conformity &
technical Documentation
Main Responsible for global medical device registration
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KARL STORZ Endoskope - Headquarter
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Director Quality & Regulatory Affairs
FDA - Official Correspondent
Safety Officer Medical Devices (§30 MPG)
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SOPRO-COMEG GmbH - Acteon Group
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SOPRO-COMEG GmbH - Acteon Group
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SOPRO-COMEG GmbH - Acteon Group
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Project: Implementation QM System (Food)
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Thermohauser
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Manager CAPA / Complaints / Improvement
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Henke Sass, Wolf GmbH
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Successful (audited by TÜV Süd) Implementation of QM System in accordance to
ISO 13485 for Production Plant Hungary (6 Month Project)
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COMEG Endoskopie GmbH & Co.KG
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Director Quality & Regulatory Affairs
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COMEG Endoskopie GmbH & Co.KG
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Director Research and Development (2002-2003)
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COMEG Endoskopie GmbH
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Developer for medical and technical devices (1993-2003) (Implementation of MDD93/42)
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COMEG Endoskopie GmbH
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