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How should you do your risk management for your Medical Device Software? ⁠ Listen to this Podcast with Bijan Elahi⁠ https://podcast.easymedicaldevice.com/225-2/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow https://www.instagram.com/p/CqVBsAksD2s/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ This week we have @Marcus Emne from @Hoodin on the podcast and I must say this discussion was really interesting.⁠ ⁠ As you may know, our discussions are not scripted so this may also derive a bit and for sure we discussed Proactive Postmarketing Surveillance additionally, we included a small chat on Artificial Intelligence to help QA RA people reach their objectives which are also applicable to Postmarketing Surveillance.⁠ ⁠ So if you want to know how AI tools can help you for doing your Postmarketing Surveillance this is the place to be.⁠ ⁠ https://podcast.easymedicaldevice.com/224-2/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow⁠ ⁠ https://www.instagram.com/p/CqDNvqwMysS/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ This week we'll talk about Vigilance Reporting.⁠ I know this is not really a topic that people want to hear about. You need to have a procedure for it but you don't want to use it.⁠ ⁠ With Adam Rae we will explain to you what this is and how this is working. We will also try to answer questions related to the requirements for Vigilance reporting worldwide.⁠ ⁠ The other point that we will discuss is how you should create your procedure for it. ⁠ ⁠ So let's see if this helps. Don't hesitate to ask us your questions. ⁠ Adam also prepared a document to download with all the information that we are discussing.⁠ ⁠ https://podcast.easymedicaldevice.com/223-2/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow⁠ https://www.instagram.com/p/CpxFmf2MWkq/?igshid=NGJjMDIxMWI=

IS YOUR SOFTWARE A CLASS I MEDICAL DEVICE?⁠ If you haven't had the chance to see this episode of LinkedIn Live, here is the replay.⁠ ⁠ We try to help Software manufacturers to understand when their Software is a Class I. Stefan and Oliver were really providing great information on this subject so you don't get surprised.⁠ ⁠ We also answered a lot of questions from the audience. So worth looking at it if you may have some doubts about your software.⁠ ⁠ https://youtu.be/EFyDm7xQ7DQ⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow⁠ #linkedinlive https://www.instagram.com/p/CpmrJzRMUra/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ I just want to remind you of something. Under EU MDR 2017/745, there is a new class that was created which is called Class Ir. This is for Class I with products that are reprocessed. And just to be clear, this is only and only for REUSABLE SURGICAL INSTRUMENTS. ⁠ ⁠ So don't miss this episode if you are manufacturing or selling REUSABLE SURGICAL INSTRUMENTS. @Tautvydas Karitonas from @Test Labs will be helping us to understand what you should prepare to be ready.⁠ ⁠ Link: https://podcast.easymedicaldevice.com/221-2/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow https://www.instagram.com/p/CpNWhdnsa4G/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ If you are planning your Biological Evaluation or Biocompatibility testing with a Laboratory, then listen to this episode where Paul Fernandez and Laura Fouzari from Groupe Icare will share with us the common mistakes that everyone do.⁠ ⁠ Let us know in the comments if you have any questions for them or maybe something that we missed on this episode. ⁠ ⁠ https://podcast.easymedicaldevice.com/219-2/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow https://www.instagram.com/p/Coo67DSMA9O/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ If you are willing to have an understanding of Post Marketing Surveillance for the US Market, then this podcast is for you.⁠ ⁠ I have invited Rob Packard that will share with us the difference in PMS between the EU and the US and also talk about an IT tool that can help you accelerate this process. Rob Packard is also planning a Webinar for PMS so don't miss it.⁠ ⁠ Check all this on the show notes.⁠ ⁠ https://podcast.easymedicaldevice.com/217-2/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow https://www.instagram.com/p/CoE8xlGsOvU/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ When we start to talk about the Risk-Benefit ratio for your Clinical Evaluation section or the Technical File, there are always some thoughts that go like "How can I do that?" or "What is the assessor expecting to see?"⁠ ⁠ So on this episode of the podcast I have invited Naveen Agarwal, Ph.D. to share with us his thoughts on the Risk-Benefit ratio. I hope this talk will help you struggle less for your next project.⁠ ⁠ Check the full episode here:https://podcast.easymedicaldevice.com/216-2/⁠ ⁠ #medicaldevicepodcast #medicaldevice #medicaldevices #regulatoryaffairs #easymedicaldevice #regulatorycompliance #compliance #meddevice #iso13485 #eumdr2017745 #eumdr #mdr2017745 #ivdr #ivdr2017746 #notifiedbody #qualitymanagement #qualitymanagementsystem #regulation #regulations #qualitysystem #medtech #podcast #podcasting #podcaster #podcastinterview #podcastshow https://www.instagram.com/p/CnzHFTKMZuP/?igshid=NGJjMDIxMWI=

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