Unsere "in House" Qualifikationen

1st and 2nd Party Auditor Medical Devices
- Auslagerung von Prozessen in der Medizinprodukteindustrie
- Validierung von Prozessen in der Medizinprodukteindustrie TUEV Rheinland Akademie
- TUEV Rheinland Akademie

Manager Regulatory Affairs Medical Devices International
- University Ulm, Professur der Fakultät Mechatronik und Medizintechnik & TUEV Rheinland Akademie

Expert Quality Management Medical Devices International
- TUEV Rheinland Akademie

Expert Technical Documentation Medical Devices
- TUEV Rheinland Akademie

Risk Management according to ISO / EN ISO 14971
- TUEV Rheinland Akademie

QM-Beauftragter (QMB) f. Medizinproduktehersteller
- TUEV Rheinland Akademie

CAPA & Co für Hersteller von Medizinprodukten
- TUEV Rheinland Akademie

Zulassung von Medizinprodukten für die USA – QSR.
- TUEV Rheinland Akademie

Qualitätsmanagementsystem nach EN ISO 13485:2016
- TUEV Rheinland Akademie



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.



„Regulatorische Anforderungen an Medizinprodukte“ MDR 2017/745
- Klinische Bewertungen
- Medical Writing
- Risk Analysis


MEDIZINPRODUKTERECHT
- Expertise in juristischen Fragen stellen wir Ihnen auch zur Verfügung.
  In Kooperation

Sprechen sie uns an.