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What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of...
North America
The FDA will shift from QSR to ISO 13485 so that their system regulations can harmonize with international practices to reduce confusion and and lessen the burden for medical device manufacturers. What is QSR Quality System Regulation (QSR), also known...
China
Overview of China’s National Medical Products Administration (formerly CFDA), their reform, medical device registration, drug registration, …
Europe
Ireland medical device regulations are unified with other European Union countries and follow the same EU MDR and IVDR regulation. However, each country has their own Regulatory Authority (RA). In the case of Ireland, such RA is HPRA. Overview All medical...
Europe
Medical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health. Greece, as a member of European Union, classifies medical devices according to their risk into four classes: I, IIb, IIb, and III....
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