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CEISO ACADEMY: our turnkey E-learning service to support you in understanding and implementing the European Regulation on Medical Devices (EU) 2017/745, which came into effect in 2021.

CEISO ACADEMY: 11 progressive E-learning modules

CEISO ACADEMY aims to facilitate the self-paced skill-building of manufacturers, authorized representatives, importers, and distributors of medical devices. This is a necessary prerequisite for greater efficiency from product design to market entry and throughout their life cycle management.

E-learning modules

E-MDR-MOD-01 – Overview of the European Medical Device Regulation

REF. E-MDR-MOD-01 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Overview of the European Medical Device Regulation module

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E-MDR-MOD-02 – Obligations of Economic Operators

REF. E-MDR-MOD-02 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Obligations of Economic Operators module presents the parties

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E-MDR-MOD-03 – EUDAMED & UDI

REF. E-MDR-MOD-03 – E-LEARNING EUROPEAN REGULATIONS Regulation (EU) 2017/745 COURSE DESCRIPTION The EUDAMED & UDI module presents the EUDAMED database

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E-MDR-MOD-04 – Market Authorization

REF. E-MDR-MOD-04 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Market Authorization module presents the principles and steps

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E-MDR-MOD-05 – Classification of Medical Devices

REF. E-MDR-MOD-05 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Classification of Medical Devices (MD) module presents the

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E-MDR-MOD-06 – Conformity Assessment

REF. E-MDR-MOD-06 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Conformity Assessment module presents the procedures to assess

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E-MDR-MOD-07 – General Safety and Performance Requirements

REF. E-MDR-MOD-07 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The General Safety and Performance Requirements (GSPR) module presents

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E-MDR-MOD-08 – Technical Documentation

REF. E-MDR-MOD-08 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Technical Documentation module presents the content of the

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E-MDR-MOD-09 – Clinical Evaluation

REF. E-MDR-MOD-09 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Clinical Evaluation module presents the clinical evaluation methodology

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E-MDR-MOD-10 – Post-Market Surveillance & Vigilance

REF. E-MDR-MOD-10 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Post-Market Surveillance & Vigilance module describes the purpose

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E-MDR-MOD-11 – Quality Management System

REF. E-MDR-MOD-11 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Quality Management System module presents the manufacturer’s obligations

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E-learning formulas

E-MDR-F-01 – Package for MANUFACTURERS

REF. E-MDR-F-01 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The MANUFACTURERS’ package is composed of 11 modules and

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E-MDR-F-02 – Package for DISTRIBUTORS

REF. E-MDR-F-02 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The DISTRIBUTORS’ package is composed of 7 modules and

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E-MDR-F-03 – Package for IMPORTERS

REF. E-MDR-F-03 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The IMPORTERS’ package is composed of 7 modules and

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E-MDR-F-04 – Package for AUTHORIZED REPRESENTATIVES

REF. E-MDR-F-04 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The AUTHORIZED REPRESENTATIVES’ package is composed of 9 modules

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E-MDR-F-05 – Package for REGULATORY AFFAIRS

REF. E-MDR-F-05 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The REGULATORY AFFAIRS package is composed of 11 modules

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E-MDR-F-06 – Package for RESEARCH & DEVELOPMENT

REF. E-MDR-F-06 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The RESEARCH & DEVELOPMENT package is composed of 6

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E-MDR-F-07 – Package for QUALITY ASSURANCE

REF. E-MDR-F-07 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The QUALITY ASSURANCE package is composed of 7 modules

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E-MDR-F-08 – Package for CLINICAL DEPARTMENTS

REF. E-MDR-F-08 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The CLINICAL DEPARTMENTS’ package is composed of 5 modules

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E-MDR-F-09 – Package for PRODUCTION/PURCHASING

REF. E-MDR-F-09 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The Production/Purchasing package is composed of 5 modules and

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E-MDR-F-10 – Package for PRODUCTION/PURCHASING

REF. E-MDR-F-10 – E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017/745 COURSE DESCRIPTION The SALES DEPARTMENTS’ package is composed of 6 modules

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