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International Medical Devices Database
- https://medicaldevices.icij.org/
- Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Try Synchromed or St. Jude . …
Quality defects and recalls | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/quality-defects-recalls
- The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally authorised medicines. Medicinal products with a quality defect …
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- As per the Medical Devices Regulation (Article 61 (2) of Regulation (EU) 2017/745 ), this type of scientific advice refers to intended clinical development strategies …
Market surveillance and vigilance - Public Health
- https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en
Medical Devices - Sector - Public Health
- https://health.ec.europa.eu/medical-devices-sector_en
- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …
Alerts, recalls and safety information: drugs and medical …
- https://www.gov.uk/drug-device-alerts
- Class 2 Medicines Recall: hameln pharma ltd, Ephedrine Hydrochloride 30 mg/ml Solution for Injection, EL (22)A/44 hameln pharma ltd is initiating a recall of the affected batches …
The European Union Medical Device Regulation – …
- https://eumdr.com/
- Document 2019-4 confirms the deadline for registering device details in EUDAMED (Annex VI Part A, section 2, and Part B) will be either; (a) 18 months after the May 2020 …
EU Medical Device Vigilance Reporting in Europe - Emergo
- https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe
- EU medical device adverse incident and FSCA reporting process These are the basic steps to reporting an incident in Europe: Reference MEDDEV 2.12/1 to determine the correct …
Medical Device Product Recall per EU Requirements - Elsmar …
- https://elsmar.com/elsmarqualityforum/threads/medical-device-product-recall-per-eu-requirements.62986/
- EU Medical Device Regulations Medical Device Product Recall per EU Requirements SGquality Feb 19, 2014 S SGquality Quite Involved in Discussions Feb 19, …
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