What are the requirements for corrective and preventive actions (CAPA) based on customer feedback?

In vitro diagnostic medical devices (IVDs) are tests used on biological samples to determine the status of a person's health. 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, ... ... in-vitro diagnostic (IVD) medical devices. Form for the registration of manufacturers and devices in vitro diagnostic medical device directive, article 10. The main importing Medical Device is diagnostic Imaging Medical Device. (about 31.5% of total Thai Medical Device market) The major country of this. Dec 6, 2024 ... IVDs must comply with the new IVD Regulation (Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hereafter abbreviated as IVDR). Jul 3, 2023 ... Therefore, there is a need to classify. IVD medical devices based on their risks to patients, users and other persons. The risk presented by a ... THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - SCHEDULE 2 Classification rules for medical devices other than IVD medical devices. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC. Apr 11, 2025 ... Any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate or diagnose disease in man. 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 ...