EMA consultation

>> YOUR LINK HERE: ___ http://youtube.com/watch?v=XTtW7_WkXm0

EU: • • MDR and IVDR communication Survey https://ec.europa.eu/eusurvey/runner/... • • EU MDR transition • o Q A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/fi... • o Flowchart to decision on the extended MDR transitional period: https://health.ec.europa.eu/document/... • o Team-NB: New MDR Transition Timeline and Notified Body Capacity: https://www.team-nb.org/wp-content/up... • o Blog Post - Erik Vollebregt . Can we fix/improve the MDR and the IVDR? https://medicaldeviceslegal.com/2023/... • • Team-NB: Transfer agreement :https://www.team-nb.org/wp-content/up... • • Notified Bodies situation :https://health.ec.europa.eu/document/... • • EMA consultation: https://www.ema.europa.eu/en/document... • Training offered: • • Vigilance Reporting: https://school.easymedicaldevice.com/... • • Audit readiness: https://school.easymedicaldevice.com/... • • Green Belt: https://school.easymedicaldevice.com/... • UK: • • CE Marking recognition: https://www.gov.uk/government/news/ce... • o Ronald Boumans article: https://www.linkedin.com/posts/ronald... • o Guardian article: https://www.theguardian.com/commentis... • o Guardian article: https://www.theguardian.com/politics/... • • 3 new UK Approved bodies :https://www.gov.uk/government/news/th... • o Approved Body list: https://www.gov.uk/government/publica... • TGA: • • Webinar : • o The new Medical devices Vigilance Program- Information for medical device Sponsors in Australia: https://www.tga.gov.au/resources/even... • o UDI: https://www.tga.gov.au/resources/even... • • Canada: • • Pre-market guidance for Machine learning-enabled : https://www.canada.ca/en/health-canad... • • USA: • • Off-the-Shelf Software :https://www.fda.gov/media/71794/download • Saudi Arabia: • • ISO 13485 for manufacturers supplies facilities : https://www.sfda.gov.sa/sites/default... • eQMS: • • SmartEye : https://smart-eye.io • Conferences • MEDXD - Berlin Germany September 26 and 27- https://medtechx.digital/ • • Afrisummit - Cairo Egypt https://www.pharmaregafrisummit.com/m... • • MEDICA - Dusseldorf Germany https://www.medica-tradefair.com/ • • Team-PRRC - Strasbourg France https://www.team-prrc.eu/page/1111392... • Podcast to listen : • • Medical Misfits episode: How to join a Tech Startup as a Medical Student: https://www.medicalmisfits.com/zoe-lee/ • • The Medtech Podcast by Karandeep Badwal: https://open.spotify.com/show/32Cvtse... • • The Med-Tech Talent Lab with Mitch Robbins: https://open.spotify.com/show/4b6r5OP... • • Life Science 360 with Harsh Thakkar: https://www.lifesciencespod.com/2079900 • • State of Medtech with Omar Khateeb: https://open.spotify.com/show/5NVrQLf... • Podcast Nostalgia • • Who should be on your Risk Management Dream Team with Naveen Agarwal: https://podcast.easymedicaldevice.com... • • Hire your QA RA employee with no Budget with Mitch Robbins: https://podcast.easymedicaldevice.com... • • Why you should automate your Software Validation with Christophe Girardey and Virginie Rochat? https://podcast.easymedicaldevice.com... • • What are the Acceptance Criteria for your Clinical Evaluation with Cesare Magri. https://podcast.easymedicaldevice.com... • • How to perform your Cleaning Validation in practice? With Enrico Allegra: https://podcast.easymedicaldevice.com... • #easymedicaldevice #medicaldevice #regulatorycompliance

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