標籤: Medical Device Reporting

2018年6月29日 - Medical Device Reporting – Alternative Summary Reporting (ASR) Program. This document contains information about the Alternative ...

Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.

2018年5月21日 - A few months ago, the FDA released a guidance on medical device reporting (MDR), an important document with which manufacturers should ...

This is a clip from a recent Q1 Productions Webinar on Medical Device Reporting of Adverse Events to the FDA ...

2016年11月8日 - Medical Device Reporting for. Manufacturers. Guidance for Industry and Food and. Drug Administration Staff. Document issued on: November 8 ...

2017年12月12日 - Any of their employees with management or supervisory responsibilities over persons with regulatory, scientific or technical responsibilities (including consultants or contractors) or whose duties relate to the collection and reporting of adverse events, becomes aware from any information (including any trend analysis) ...

Medical device reporting regulations (MDR) in both the United States and the European Union (EU) require that adverse events relating to medical devices be ...