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Philippines FDA has announced the implementation of a new regulatory framework for medical devices.
#RegDesk#Philippines#MedicalDeviceshttps://hubs.ly/H0mSnJs0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The MHRA has released guidance regarding notified bodies and grace periods.
#RegDesk#MHRA#MedicalDeviceshttps://hubs.ly/H0mSg120Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The FDA has launched their PEPFAR drug database, used for various antiretroviral HIV drugs available to purchase through the President’s Emergency Plan for AIDS Relief (PEPFAR).
#RegDesk#FDA#PEPFARhttps://hubs.ly/H0mQQRj0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The MFDS has released guidance surrounding the topics of imported devices and scarce/urgently needed medical devices.
#RegDesk#MFDS#Guidancehttps://hubs.ly/H0mQ2Cv0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Genus Lifesciences has sued the FDA because they believe the agency has acted unlawfully in allowing a competitor to bring certain products to market.
#RegDesk#FDA#MedicalDeviceshttps://hubs.ly/H0mPPyG0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The MHRA has released guidance on clinical investigations in order to assist manufacturers in complying with any and all applicable requirements.
#RegDesk#MHRA#ClinicalInvestigationshttps://hubs.ly/H0mNY5f0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The FDA has released a statement explaining their development process to combat Coronavirus.
#RegDesk#FDA#Coronavirushttps://hubs.ly/H0mNHSL0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The FDA has released guidance surrounding premarket notification submissions for arthroscopy pump tubing sets.
#RegDesk#FDA#Guidancehttps://hubs.ly/H0mMD8f0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
In 2019, Montenegro adopted the Law on Medical Devices. This established general principles related to manufacturing, distributing and supervising medical devices on the domestic market.
#RegDesk#MedicalDevices#Montenegrohttps://hubs.ly/H0mLXCv0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Don't forget to register for tomorrow's
#WebinarWednesday for an update on EEU Regulations in Russia! https://hubs.ly/H0mMthj0 pic.twitter.com/GAWtV1PcNt
Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The SFDA has released guidance surrounding innovative devices and recognized standards for medical devices.
#RegDesk#SFDA#MedicalDeviceshttps://hubs.ly/H0mLJ7f0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The FDA warns that several types of GE Healthcare devices could be hacked into to silence alarms, generate false alarms and interfere with alarms of patient monitors.
#RegDesk#FDA#CyberSecurityhttps://hubs.ly/H0mLy5z0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The FDA has published guidance dedicated to 510(k) premarket notification submissions related to computer-assisted detection devices applied to radiology images and radiology device data.
#RegDesk#FDA#CADehttps://hubs.ly/H0mJtHw0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The EC announced that three more notified bodies are awaiting publication in the Nando database as designated under the MDR.
#RegDesk#MDR#EC#NotifiedBodieshttps://hubs.ly/H0mJhgd0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Australia's TGA has issued a consultation paper dedicated to the fees and charges associated with medical device registration.
#RegDesk#TGA#MedicalDeviceshttps://hubs.ly/H0mHlgK0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The FDA has classified three radiology devices into Class II.
#RegDesk#FDA#MedicalDeviceClassificationhttps://hubs.ly/H0mH5YP0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Bahrain releases new medical device regulation guidelines in order to assist medical device manufacturers in maintaining compliance with the applicable requirements.
#RegDesk#Bahrain#MedicalDeviceshttps://hubs.ly/H0mGvXm0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
A report from the European Medicines Agency released Monday sets out recommendations to unlock the potential of data in medicines regulation.
#RegDesk#EMA#Datahttps://hubs.ly/H0mG7XV0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Medical Device companies are looking for further clarification regarding the legal status of Clinical Decision Supporting (CDS) software from the FDA.
#RegDesk#FDA#CDSSoftwarehttps://hubs.ly/H0mFszq0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
California's Mojo Vision is in the process of developing a smart contact lens with a built-in display, providing patient information to prevent loss of focus.
#RegDesk#MedicalDevices#Regulationshttps://hubs.ly/H0mFkdr0Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi
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