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https://www.um.edu.mt/library/oar/handle/123456789/113815| Title: | Risks in medical device vigilance |
| Authors: | Almojero, Danielle Claire E. Serracino-Inglott, Anthony Attard Pizzuto, Maresca |
| Keywords: | Medical instruments and apparatus -- Safety measures -- Malta Medical instruments and apparatus -- Safety measures -- Standards Medical instruments and apparatus -- Risk assessment Medicines Authority (Malta) |
| Issue Date: | 2023-09 |
| Publisher: | International Pharmaceutical Federation (FIP) |
| Citation: | Almojero, D. C. E., Serracino-Inglott, A., & Attard Pizzuto, M. (2023, Sep). Risks in medical device vigilance. Poster session presented at the International Pharmaceutical Federation 81st World Congress of Pharmacy, Brisbane, Australia. |
| Abstract: | Introduction: Medical devices are products that vary from simple bandages to artificial bones, and intensive security measures are adopted from the approval up to the release of the device to the market for the safety of its users. Medical Device Compliance Exchange Form (CEF) is a communication tool used for data exchange about medical devices between Competent Authorities ( CA) and Designating Authorities (DA) in specific cases including Notified Bodies (NB) within the European Union (EU). In Malta, the Medicines Authority (MMA) is the CA for ensuring medical devices' safety, incident reports and investigation. |
| URI: | https://www.um.edu.mt/library/oar/handle/123456789/113815 |
| Appears in Collections: | Scholarly Works - FacM&SPha |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| Risks in medical device vigilance 2023.pdf | 652.81 kB | Adobe PDF | View/Open |
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