Integrated course internal auditors according to ISO 13485: 2016, responsible for vigilance, risk management for medical devices
12.04.2022 2022-05-26 12:44Integrated course internal auditors according to ISO 13485: 2016, responsible for vigilance, risk management for medical devices
Integrated course internal auditors according to ISO 13485: 2016, responsible for vigilance, risk management for medical devices
(according to ISO 13485: 2016, IAF MD-9: 2017, ISO 14971: 2019, ISO 19011)
- Duration: 3 days
- Period: 27 – 29.04.2022
COURSE OBJECTIVES
- Knowledge of the requirements of the ISO 13485: 2016 standard for “Medical devices – DM. Quality Management System. Requirements for regulatory purposes “
- Assume the obligations of manufacturers, importers, distributors, service providers and users in the field of DM to be fulfilled in order to comply with the requirements of Regulation 745
- IAF MD 9 – Application of ISO / IEC 17021-1 in the field of DM quality.
- Classification of medical devices according to Regulation 745, of harmonized standards, according to the IAF MD Guide 9
- Knowledge of the requirements of the ISO 14971: 2019 standard for medical device risk management – risk analysis – DM benefit
- Training the skills needed to perform the audit in the field of DM, according to ISO 19011: 2018
- Corrective actions and preventive actions
Target group:
- Medical device manufacturers
- Service providers that must comply with legal and regulated requirements
- Companies that develop, design, manufacture and distribute, store, rent, import and market medical devices
- The companies that perform: service, installation, installation, commissioning – medical devices
- Companies that design, manufacture and assemble medical devices, reagents, consumables
- Companies that produce components similar to medical devices, accessories, packaging, disinfectants
- Companies participating in the endowment or rehabilitation of hospitals
- Radiology-Imaging, Mammography, MRI Centers / Laboratories
- Medical device packaging companies, manufacturers of packaging for medicines and medical devices, etc.
LECTURER:
Mr. Mugurel Vintilescu
Specialist in medical equipment and instruments, with over 30 years of experience in the design, execution, installation and maintenance of medical devices.
Over 15 years as Chief Auditor for Quality Management Systems
CONDITIONS OF PARTICIPATION AND PAYMENT
Special price / person: from 1800 RON + reduced VAT to 1490 RON + VAT for registration until April 21, 2022
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, the DIPLOMA OF INTERNAL AUDITOR is issued.
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Curriculum
- Final test for obtaining the graduation certificate
- Case studies
- Documents accompanying DM. Declaration of Conformity, ISO, CE Certificates, Technical Specification, Work / use instructions, Installation / use / operation manual, FTS, notices, notifications, analysis bulletins, test reports, etc.
- Labeling and packaging DM – ISO 15223/2016
- Risk management analysis and reporting: reporting, incident analysis, market surveillance
- Identification, traceability and life cycle of DM (UDI system – EUDAMED)
- Technical product file TF, DMR
- DM risk management requirements, DM risk-benefit analysis – ISO 14971/2019
- Terminology. Definitions. DM classification according to Regulation 745 and harmonized standards (ISO 13485/2016, ISO 14971/2019, IAF MD9)
- Responsibilities and responsibilities of the person designated as RESPONSIBLE FOR SURVEILLANCE
- Hazards identification