RL12 – Medical Device Regulation (EU) 2017/745 – Introduction to the Regulation
REF. RL12 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION The design, production and marketing of Medical Devices in Europe
You work in a demanding regulatory and normative environment. Your employees’ efficiency is an essential part of your company’s performance. We support the development and maintenance of your teams’ skills.
All our trainings courses can be carried out either INTER or INTRA, in-person or in a virtual classroom. We can also design tailor-made training courses to meet your needs.
*IP = In-person / Virt. = Virtual Class
REF. RL12 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION The design, production and marketing of Medical Devices in Europe
REF. RL13 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION The design, production and marketing of In Vitro Diagnostic Medical
REF. RL14 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION To place Medical Devices on the market in Europe, the
REF. RL15 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION To place In Vitro Diagnostic Medical Devices on the market
REF. RL07 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION When Medical Devices (MD) are placed on the market in
REF. RL20 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION The demonstration of a Medical Device’s compliance with essential requirements
REF. RL21 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION The demonstration of an In Vitro Diagnostic Medical Device’s compliance
REF. RL22 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION To place Medical Devices on the market in Europe, the
REF. RL23 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION To place In Vitro Diagnostic Medical Devices (IVDMD) on the
REF. RL24 – INTRA / INTER EUROPEAN REGULATIONS COURSE DESCRIPTION When in vitro diagnostic medical devices (IVDMD) are placed on
REF. RL08 – INTRA / INTER INTERNATIONAL REGULATIONS COURSE DESCRIPTION Compliance with FDA (Food and Drug Administration) requirements is mandatory
REF. MQ03 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION CE-marking requires the implementation of a Quality organization. European standard
REF. MQ05 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION This course will allow you to acquire practical knowledge to
REF. MQ06 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION Applicable regulations require control of the production of medical devices
REF. MQ10 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION This course will allow you to acquire practical knowledge to
REF. MQ03 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION CE-marking requires the implementation of a Quality organization. European standard
REF. MQ05 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION This course will allow you to acquire practical knowledge to
REF. MQ06 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION Applicable regulations require control of the production of medical devices
REF. MQ10 – INTRA / INTER QUALITY SYSTEM COURSE DESCRIPTION This course will allow you to acquire practical knowledge to
REF. ST02 – INTRA / INTER PROCESSES COURSE DESCRIPTION International regulations that govern market authorizations for Medical Devices require process
REF. ST03 – INTRA / INTER PROCESSES COURSE DESCRIPTION International regulations that govern market authorization for Medical Devices require process
REF. ST04 – INTRA / INTER PROCESSES COURSE DESCRIPTION International regulations that govern market authorization for Medical Devices require process
REF. ST05 – INTRA / INTER PROCESSES COURSE DESCRIPTION International regulations that govern market authorization for Medical Devices require process
REF. GR02 – INTRA / INTER MANAGING RISKS COURSE DESCRIPTION This training will allow you to update or acquire practical
REF. GR03 – INTRA / INTER MANAGING RISKS COURSE DESCRIPTION At the end of this course, participants will understand the
REF. GR04 – INTRA / INTER MANAGING RISKS COURSE DESCRIPTION To place Medical Devices (MD) on the market in Europe,
REF. GR05 – INTRA / INTER MANAGING RISKS COURSE DESCRIPTION At the end of the course, participants will better understand
REF. GR06 – INTRA / INTER MANAGING RISKS COURSE DESCRIPTION To place Medical Devices on the market in Europe, the
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Consulting, Clinical Services, Training. We assist you in bringing your medical devices to market.