Requirements for importers, distributors, users and service providers. Good practice of distribution / storage of medical devices.
Period: 18.04.2022

COURSE OBJECTIVES

• Knowledge of the requirements of the republished Law 95/2006, regarding the health care reform,
• Obligations of manufacturers, importers, distributors of medical devices to be met to comply with the requirements of Law 95/2006 and WHO 566/2020 for the approval of methodological rules for the application of Title XX of Law 95/2006, regarding the approval of activities in the field of medical devices
• Obligations of manufacturers, importers, distributors of medical devices to be fulfilled to comply with the requirements of GD 54/2009 on the conditions of placing medical devices on the market, with subsequent amendments, GD 798/2003 on establishing the conditions of placing on the market and use of medical devices for in vitro diagnosis, as subsequently amended and supplemented, GD 55/2009 on active implantable medical devices and WHO 1009/2016
• Obligations of manufacturers, importers, distributors of medical devices to comply with the requirements of Regulation 745/2017

TARGET GROUP

• Manufacturers, importers, distributors, users of medical devices
• Companies that perform service activities, installation, installation, commissioning – medical devices

COURSE PURPOSE AND OBJECTIVES

• Knowledge of the obligations that must be fulfilled in order to comply with the regulatory requirements applicable to medical devices.
• Ability of the learner to identify medical devices and accompanying documents in accordance with the regulations applicable to the field of DM.

ACQUIRED COMPETENCES

• Knowledge of the requirements of the previously presented regulatory documents
• Implementing regulatory requirements at the organization level
• The course graduate will be able to train the staff involved in the specific DM activity.

LECTURER:
Mr. NEAGU GHEORGHE
Specialist in the field of medical devices, with 44 years of experience in the installation and maintenance of medical devices, supervision and control of compliance with the conditions of placing medical devices on the market, development and updating of specific procedures, monitoring of legislative changes and their implementation, analysis and verification incidents in the use of reported medical devices, resolving petitions and complaints in the field.

CONDITIONS OF PARTICIPATION AND PAYMENT

Price: 990 RON + VAT
For details please contact us by e-mail at cristina.statescu@certinspect.ro or by phone: 0722 105 099
At the end of the course, a valid Participation Diploma is issued in relation to NAMMD