RegDesk, Inc.

@RegDesk

On-demand, in-country regulatory intelligence and compliance experts for medical device, mobile health & pharma companies.

Philadelphia, PA
Vrijeme pridruživanja: ožujak 2014.

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  1. prije 12 sati

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

    Poništi
  2. prije 15 sati

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

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  3. 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).

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  4. 30. sij

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

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  5. 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.

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  6. 29. sij

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

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  7. 29. sij

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

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  8. 28. sij

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

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  9. 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.

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  10. 28. sij

    Don't forget to register for tomorrow's for an update on EEU Regulations in Russia!

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  11. 27. sij

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

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  12. 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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  13. 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.

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  14. 23. sij

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

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  15. 22. sij

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

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  16. 22. sij

    The FDA has classified three radiology devices into Class II.

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  17. 21. sij

    Bahrain releases new medical device regulation guidelines in order to assist medical device manufacturers in maintaining compliance with the applicable requirements.

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  18. 21. sij

    A report from the European Medicines Agency released Monday sets out recommendations to unlock the potential of data in medicines regulation.

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  19. 20. sij

    Medical Device companies are looking for further clarification regarding the legal status of Clinical Decision Supporting (CDS) software from the FDA.

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  20. 20. sij

    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.

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