Please describe your role As Quality Assurance Manager, I’m responsible for all QA activities at Contamac. I have a great team comprising of our Quality Engineer, QA Technician and QA Administrator, and together we look after the Quality Management System; conducting root cause analysis, implementing corrective and preventive action,...
Read moreEudamed is the European Database for Medical Devices and is one of the corner stones of the MDR 2017/745 for Medical Devices and MDR 2017/746 for In Vitro Diagnostic Medical Devices. The goal is to enhance the overall transparency for the sector and provide better access to information for...
Read moreThe Medical Device Regulation (EU) 2017/745 puts great emphasis on the legal responsibility for the final device being that of the legal manufacturer. However, achieving MDR certification will nearly always depend to some extent on a manufacturer having a dependable supplier; one who knows of the regulatory obligations which...
Read moreThe United States Food and Drug Administration (FDA) recently announced a significant change in its regulatory framework, shifting from the current Quality System (QS) Regulation (21 CFR 820) to a new system known as the Quality Management System Regulation (QMSR). QMSR will go into effect two years after the...
Read moreODC Industries, a subsidiary of Contamac Ltd, are a medical device manufacturer based in France who produce a variety of products for the ophthalmic industry. We interview Martina Clifford, ODC Industries’ Quality Director to get an overview of her role and the significance of quality assurance in the Medical...
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