What are the requirements for post-market monitoring in Australia?

Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements. “Modified Device” is a medical device(or an IVD) that is equivalent in 'Intended Use', 'Mechanism of Action(MoA)', 'Raw Materials(Limited to implanted/contacted ... In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health. The industry employs about 75 000 people ... The In Vitro Diagnostic Devices Regulation applies since 26 May 2022. It repeals Directive 98/79/EC of the European Parliament and of the Council on in vitro ... Dec 21, 2021 ... What is an IVD medical device? An IVD medical device is an in vitro diagnostic medical device intended to be used for the testing of human ... Sep 26, 2012 ... The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists of Directive 98/79/EC of the European ... Jan 30, 2025 ... Apply for this Permanent full-time, IVD Medical Device Lead Auditor job in Oldbury on Reed.co.uk, the UK's #1 job site. The documents below detail the requirements that UNICEF applies to medical devices, in vitro diagnostics devices and personal protective equipment (PPE). Waters Corporation manufactures IVD medical devices that offer clinical diagnostic laboratories an alternative to LC-MS/MS systems manufactured for clinical ... 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, ...