What are the responsibilities of medical device manufacturers in Canada?

Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) ... Mar 25, 2024 ... Below are 7 key steps in the CE certification process, from application submission to certificate issuance. The document is intended to provide non-binding guidance for use in the regulation of medical devices including In Vitro Diagnostic (IVD) medical devices, and. Dec 20, 2024 ... What is an in vitro diagnostic product (IVD)? ... Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are ... "In vitro diagnostic medical device' (IVD') means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro ... Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements. Veristat offers a team of scientific-minded regulatory experts who understand how to develop the documentation and elaboration needed to support the CE mark ... Nov 10, 2024 ... Medical device and IVD product manufacturers seeking market entry in Australia should note that Expressions of Interest (EOI) for ... THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - SCHEDULE 2 Classification rules for medical devices other than IVD medical devices. The role will also include auditing to EU MDR (EU medical device regulation 2017/745), UK MDR 2002 for medical devices and IVDs, ISO 13485 and MDSAP, ...