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Click here for the online version of the Newsletter.
With this newsletter we would like to inform you about the following current GMP trends with regard to Medical Devices. |
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1. FDA's Current Publications for Manufacturers of Medical Devices
In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more in the selection of FDA publications of the last months. |
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2. Combination Products
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3. FDA's Plans with regard to Medical Devices in 2017
What the FDA plans with regard to the regulation of medical devices can be found in a report on Regulatory Science Priorities. |
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4. GMP for Medical Devices
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5. IMDRF publishes Guidance Draft on Clinical Studies with Software as a Medical Device
The IMDRF (International Medical Devices Regulator Forum) is the successor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaulation". |
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6. In case you missed the previous GMP Newsletter, here are the news from the last GMP Newsletter:
For further recent news please go here. |
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7. Forthcoming GMP/FDA Events
Here you will find an updated overview of forthcoming education courses and conferences. |
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Yours sincerely, The ECA Academy We have entrusted the following service provider
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