Rezultati pretraživanja
  1. 30. sij

    The MFDS has released guidance surrounding the topics of imported devices and scarce/urgently needed medical devices.

  2. prije 15 sati

    The MHRA has released guidance regarding notified bodies and grace periods.

  3. 23. sij

    The EC announced that three more notified bodies are awaiting publication in the Nando database as designated under the MDR.

  4. prije 12 sati

    Philippines FDA has announced the implementation of a new regulatory framework for medical devices.

  5. 22. sij

    Australia's TGA has issued a consultation paper dedicated to the fees and charges associated with medical device registration.

  6. 7. pro 2019.
  7. 23. sij

    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.

  8. 5. pro 2019.

    The IMDRF has released new clinical guidelines regarding clinical evaluations, investigations, and evidence.     

  9. 30. sij

    Genus Lifesciences has sued the FDA because they believe the agency has acted unlawfully in allowing a competitor to bring certain products to market.

  10. 31. sij

    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).

  11. 29. sij

    The MHRA has released guidance on clinical investigations in order to assist manufacturers in complying with any and all applicable requirements.

  12. 29. sij

    The FDA has released a statement explaining their development process to combat Coronavirus.

  13. 28. sij

    The FDA has released guidance surrounding premarket notification submissions for arthroscopy pump tubing sets.

  14. 28. sij

    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.

  15. 27. sij

    The SFDA has released guidance surrounding innovative devices and recognized standards for medical devices.

  16. 27. sij

    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.

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