Dr. Ute Sorger
Auditor, CEO Institut Dr. Sorger
Institut Dr. Sorger GmbH
Switzerland, Canton Zug, founded 2011
Dr. med. dent. Ute Sorger works as CEO of the consulting company and independent auditor in the field of medical devices, in particular DIN EN ISO 13485.
Your concern is important to us and will be treated with the greatest care and expertise.
Valid technical documentation and valid QM
quality management system
risk management
systems for monitoring clinical trials after they have been placed on the market
clinical evaluation, case study
clinical follow-up observation after the placing on the market
1st and 2nd Party Auditor Medical Devices
Manager Regulatory Affairs Medical Devices International
Expert Quality Management Medical Devices International
Expert Technical Documentation Medical Devices
1st and 2nd Party Auditor Medical Devices
- Outsourcing of processes in the medical device industry
- Validation of processes in the medical device industry TUEV Rheinland Akademie
- TUEV Rhineland Academy
Manager Regulatory Affairs Medical Devices International
- University of Ulm, professorship in the Faculty of Mechatronics and Medical Technology & TUEV Rhineland Academy
Expert Quality Management Medical Devices International
- TUEV Rheinland Academy
Expert Technical Documentation Medical Devices
- TUEV Rheinland Academy
Risk Management according to ISO / EN ISO 14971
- TUEV Rheinland Academy
QM representative (QMB) for medical device manufacturers
- TUEV Rheinland Academy
CAPA & Co for manufacturers of medical devices
- TUEV Rheinland Academy
Medical Device Approval for the USA - QSR.
- TUEV Rheinland Academy
Quality management system according to EN ISO 13485: 2016
- TUEV Rheinland Academy
Training Course Auditors and Experts of the (former) Notified Body Switzerland:
- The new documentation of the notified body Switzerland and the application for audits according to ISO 13485 and conformity assessments according directive 93/42/EEC
- The European CE marking approach and ist legal and operational basis.
- Conformity assessment routes and quality assurance requirements fort he various risk classes.
- Importance and roll of clinical data.
- Regulatory significance of risk management and process validation.
- Steps required für post market surveillance for different risk classes.
- Criteria for reporting adverse incidents under the vigilance system.
- Manufacturers regulatory responsibilities, including reporting of changes to products and the QMS System to the Notified Body.
- Technical Documentation requirements.
- Relevance of recent changes tot he Medical Device Directives.
- Surveillance audits, unannounced audits and supplier audits in compliance with the directives.
"Regulatory Requirements for Medical Devices" MDR 2017/745
- Clinical evaluations
- Medical Writing
- Risk Analysis
MEDICAL DEVICE LAW
- We also provide you with expertise in legal matters.
In Cooperation
Contact us
Studied dentistry and qualified as a dentist at the Justus Liebig University in Giessen.
Doctoral thesis at the Christian-Albrechts-Universität zu Kiel: "Mechanical investigations of lag screw prototypes with the help of a newly developed test apparatus" at the Center for Oral and Maxillofacial Medicine, Clinic for Oral and Maxillofacial Surgery & at the Department of Materials Science at the Christian Clinic -Albrechts University in Kiel.
Additional courses: Fernuniversität Hagen, Business Administration - University of Giessen: Newer foreign languages
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