×

Home Top Podcaster Networks By Language By Country By Category About Us Contact Us Faqs Features News & Blogs Privacy Policy Terms Of Use

☰

Search

Home > Medical Device made Easy Podcast > Medical Device News – April 2020 Regulatory Update


	Podcast:		Medical Device made Easy Podcast
	Episode:		Medical Device News – April 2020 Regulatory Update
	Category:		Business
	Duration:		00:00:00
	Publish Date:		2020-05-04 00:00:00
	Description:		In this episode of the Medical Device made Easy Podcast, we will review; How Coronavirus is shaking the Medical Device World? The Notified Body Situation The Anniversary of the Mini-Course MDR 2017/745 New MDCG guidance released in April 2020 All the events that happened at Easy Medical Device Check the links section to find all the sources for the information provided. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized 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… Links CORONAVIRUS LinkedIn Poll 1 year delay: https://www.linkedin.com/posts/melazzouzi_medicaldevices-eumdr-easymedicaldevice-activity-6657212846474092544-vVKi Easy Medical Device Pack Template: https://easymedicaldevice.com/shop Commission guidance FAQ: https://ec.europa.eu/docsroom/documents/40607/attachments/1/translations/en/renditions/native UK MHRA exemption: https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak MHRA flexibility: https://www.gov.uk/guidance/mhra-regulatory-flexibilities-resulting-from-coronavirus-covid-19 Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak https://www.gov.uk/government/publications/specification-for-ventilators-to-be-used-in-uk-hospitals-during-the-coronavirus-covid-19-outbreak ISO Standards available during Coronavirus: https://www.iso.org/covid19 NOTIFIED BODY SITUATION NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main MINI-COURSE MDR 2017/745 Course link: https://easymedicaldevice.com/mdr MDCG GUIDANCE MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en MDCG 2020-5: Guidance on Clinical Evaluation – Equivalence https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en MDCG 2020-6: Guidance on Sufficient Clinical Evidence for Legacy Devices https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en MDCG 2020-7: Guidance on PMCF Plan Template https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en MDCG 2020-8: Guidance on PMCF Evaluation Report Template https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en MDCG 2020-9: Regulatory requirements for ventilators and related accessories https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en MDCG 2020-3 rev1: Interpretation of Article 54(2)b https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en PODCAST EPISODES Episode 71 – MDR & Drug-Device Combination products with Theresa Jeary https://podcast.easymedicaldevice.com/71/ Medical Device School: Why are Staff hiding problems to QA RA departments with Karandeep Badwal https://podcast.easymedicaldevice.com/mds11/ Episode 72 – The 1-year Delay of EU MDR 2017/745 with Erik Vollebregt https://podcast.easymedicaldevice.com/72/ Episode 73 – Calculate your Sample Size with Jon Bergsteinsson https://podcast.easymedicaldevice.com/73/ LINKEDIN LIVE How to certify your class Ir Reusable Surgical Instruments (EU MDR 2017/745) https://youtu.be/-sSo-_V0zbY Workshop: How to write your Intended Purpose? [Medical Device case study] https://www.youtube.com/watch?v=t4RaJKC9xeM The post Medical Device News – April 2020 Regulatory Update appeared first on Medical Device made Easy Podcast.
	Total Play:		0