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Medical Device News – November 2021 latest update



In this episode of the Podcast we will review:
– IVDR proposal to delay transition periods
– Cobalt on medical devices as CMR
– Artificial Intelligence
– MDCG guidance
– Notified Body overview

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► Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, Online courses…

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► Links from the Video

• Implementing Rolling Plan https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf
• IVDR proposal for new transition period: https://ec.europa.eu/commission/presscorner/detail/en/ip_21_5209 https://ec.europa.eu/commission/presscorner/detail/en/qanda_21_5210
• PDF Q&A: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_21_5210/QANDA_21_5210_EN.pdf
• Draft Regulation: https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_2017-746-regulation_2021-amendment_en.pdf
• ANSM: From October 1st 2021 Cobalt as CMR following 2020/2017: https://ansm.sante.fr/actualites/evolution-reglementaire-impactant-les-dispositifs-medicaux-qui-contiennent-du-cobalt
• Listed on CLP 1272/2008 Annex VI: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=celex%3A32008R1272
• Guideline to justify CMR is called SCHEER which provides elements to justify with benefit/risk analysis. https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_015.pdf
• TEAM NB – Proposal for Notified Body Opinion Template for Article 117: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Article117-NB-Opinion-Template-V1.pdf
• TEAM NB – European Artificial Intelligence: https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Artificial-Intelligence.pdf
• UK MHRA – US, Canada and UK identified 10 guiding principles for AI softwares https://www.gov.uk/government/publications/good-machine-learning-practice-for-medical-device-development-guiding-principles
• UK MHRA – Consultation on Futur Regulation https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom
• UK MHRA – Infusion Pump T34 from BD https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1026856/T34_syringe_pump_guidance_for_gov-uk.pdf
• MHRA Board meeting held in public – eventbrite: https://www.eventbrite.co.uk/e/mhra-board-meeting-held-in-public-tickets-195778337277
• Turkey
○ EU MDR 2017/745 – May 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek1TbbicihazGBOKbeyanmetni_83778294-b01e-47a2-b868-e33c1dd02bc3.pdf
○ EU IVDR 2017/746 – Sept 2021 https://titck.gov.tr/storage/Archive/2021/announcement/Ek2InvitroGBOKbeyanmetni_1d33cd35-632a-4abb-87ea-803ef67f4977.pdf
• Philippine – FDA Circular for retailers of Medical Devices – License to sell medical devices is needed https://www.fda.gov.ph/wp-content/uploads/2021/10/FDA-Circular-No.2021-021.pdf
• Thailand FDA – HAS Singapore – Regulatory reliance program: https://bit.ly/3nN1PBo
• Japan – PMDA update https://www.pmda.go.jp/files/000243366.pdf
○ Online platform to learn the regulation in Japan: https://www.pmda.go.jp/english/int-activities/training-center/0005.html
○ Other course: https://www.pmda.go.jp/english/int-activities/training-center/0006.html

► EVENTS
• ACRAS – Nov 24th and 25th https://acras.me/

► NOTIFIED BODIES
• Overview of Notified Body Situation https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/notifiedbodies_overview_en.pdf

► GUIDANCE
• MDCG 2021-24 – Classification https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
• MDCG 2021-25 Legacy devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_25_en.pdf
• MDCG 2021-26 Article 16 Importer Distr Q&A https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_26_en.pdf

► PODCAST
• Episode 149 – EUDAMED Update with Richard Houlihan https://podcast.easymedicaldevice.com/149/
• Episode 150 – CMR substances with Ana Luiza Cassin Duz https://podcast.easymedicaldevice.com/150/
• Episode 151 – IVDR is not postponed with Erik Vollebregt https://podcast.easymedicaldevice.com/151/

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#EasyMedicaldevice #medicaldevices #compliance

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