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Medical Device News – March 2022 Regulatory Update



Here is the Medical Device News that is providing your Regulatory update for March 2022
Below are the links that were discussed during the podcast.

HOT TOPICS
► IVDR
■ Common Specification certain Class D IVD – https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-diagnostic-medical-devices-common-specifications_en
■ Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – https://ec.europa.eu/health/document/download/558ede8b-ff9a-4a8f-bb9d-d61e4a515b6a_en

EXPERT PANEL IVD:
https://ec.europa.eu/health/system/files/2022-02/pecp-ivd-2021-0000012-view_en.pdf
https://ec.europa.eu/health/system/files/2022-02/pecp-ivd-2021-0000013-view_en.pdf
https://ec.europa.eu/health/system/files/2022-02/pecp-ivd-2021-0000015-view_en.pdf
https://ec.europa.eu/health/system/files/2022-02/pecp-ivd-2021-0000011-view_en.pdf

► SPAIN
■ Registration of those responsible for placing medical devices on the market – https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/la-aemps-pone-en-marcha-una-nueva-rps-para-el-registro-de-responsables-de-la-puesta-en-el-mercado-de-productos-sanitarios/

► UK
■ Pilot world-leading approach to improving ethical adoption of AI in healthcare – https://www.gov.uk/government/news/uk-to-pilot-world-leading-approach-to-improve-ethical-adoption-of-ai-in-healthcare
Ireland – Certificate of Free Sale – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0026-guide-to-applications-for-certificates-of-free-sale-for-medical-devices-v10.pdf?sfvrsn=55

TRAINING
■ MDR Training https://school.easymedicaldevice.com/emd-course/

WORLDWIDE
►USA
■ How to report Medical Device Problems – https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files
■ QMS amendments https://www.federalregister.gov/public-inspection/2022-03227/medical-devices-quality-system-regulation
https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions
https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

►SAUDI ARABIA
■ Guidance on Innovation Medical Devices https://www.sfda.gov.sa/sites/default/files/2022-02/InnovativeMDSG002_0.pdf
■ Application form for issuance of Saudi Free Sale Certificate https://www.sfda.gov.sa/sites/default/files/2022-02/App-Form-Issuance-Saudi-Free-Sale-CertifA_0.docx

►CHINA
■ Guidance for compilation of Technical Requirement for MD Products – https://www.cmde.org.cn/CL0112/25070.html

GUIDANCES
■ MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR – https://ec.europa.eu/health/document/download/e5714b2b-e98b-4fce-b5ff-d9141a8f30e1_en
■ MDCG 2022-3 – Verification of manufactured class D IVDs by Notified Bodies – https://ec.europa.eu/health/document/download/ebbc4f6a-4945-4d5d-9c22-9bc1aafc5532_en
■ Ireland – Medical Device Classification guidance – https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0004-guide-to-classification-of-a-medical-device-v3.pdf?sfvrsn=15

NOSTALGIA
■ Podcast Episode 166 – Why Design History File DHF is so important? With Alexandros Savvidis https://podcast.easymedicaldevice.com/166/
■ Podcast Episode 167 – How to be great at Management Reviews https://podcast.easymedicaldevice.com/167/
■ Podcast Episode 168 – Why would you need a Swiss Authorized Representative and Importer? https://podcast.easymedicaldevice.com/168/

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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 company 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, Podcast, Online courses…
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► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

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#EasyMedicalDevice #medicaldevice #compliance

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