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Did extension of the EU Medical Device Regulations (MDR) really give you more time to comply? youtube.com/live/RZhGzO8sj…
youtube.com
YouTube
Did extension of the EU Medical Device Regulations (MDR) really give...
510k Electronic Submission Guidance for FDA 510k Submissions medicaldeviceacademy.com/510k-electroni… via @Medical Device Academy
medicaldeviceacademy.com
510k Electronic Submission Guidance for FDA 510k Submissions
This is an overview of the updated 510k electronic submission guidance document that was released by the FDA on October 2, 2023.
Robert Packard is systematically updating our 510(k) Course Series and templates to reflect changes within the FDA's submission process to include the death of the E-Copy, and adoption of the new E-Star process. medicaldeviceacademy.com/510k-course/
medicaldeviceacademy.com
510k Course Webinars and Templates for the FDA eSTAR
The 510k course includes 36 new eSTAR webinars, 36+ historical webinars, electronic templates for your next 510k submission, and the eBook.
Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR. fda.gov/medical-device…
Last month the Medical Device Coordinators Group released a batch of new guidance documents. These guidance documents pertain to the application of the MDR and IVDR to your QMS. ec.europa.eu/health/medical…
Blood Collection Tube Shortage Regulatory Bullet Points- The FDA has recently added ALL blood specimen collection tubes to the 506j Device Shortage List. It includes Product Codes GIM and JKA. fda.gov/medical-device…
Uh Oh! Does your quality management system have a plan for preserving your medical device until it reaches point of use? If not, this might be a great time for a preventive action for all of you ISO 13485:2016 compliant companies out there. vtdigger.org/2022/01/14/are…
vtdigger.org
Are antigen tests OK to use in the cold? Most likely, experts say. - VTDigger
The brand sent to Vermonters under a new pilot program will probably hold up just fine, despite what the box says.
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