Easy Medical Device

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=

Guiding Light - Remember that consultants are here to help you pass the EU MDR situation.⁠ ⁠ #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/CnxOAgQsnFT/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ Be careful on this podcast there is an action that expires tomorrow. So have a look as this can help you improve the regulation. ⁠ ⁠ In this episode, Erik Vollebregt is helping us to understand the situation after the publication of the Extension Proposal made by the commission. We will explain to you the surprises that we find inside and how this may help you in the future. ⁠ ⁠ I placed on the show notes the links to the different documents so don't hesitate to check them. And Erik also prepared something for you.⁠ ⁠ ⁠ https://podcast.easymedicaldevice.com/215-2/⁠ ⁠ #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/CnhQegZM-S3/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ Today we have a special episode with @Omar M. Khateeb where we will try to improve the relationship between QA RA and Marketing.⁠ You may have had experience with other departments within your company that are not liking to discuss with QA RA and we will review that today and use Marketing as an example.⁠ ⁠ So don't hesitate to put comments here if you are experiencing the same and how you had improved the situation.⁠ ⁠ https://podcast.easymedicaldevice.com/214-2/⁠ ⁠ #emdchallenge #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/CnOx6sHsExO/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ Happy New Year 2023 to all of you. Wishing you Health and Happiness.⁠ ⁠ I prepared for you the January 2023 Regulatory Update. In this episode we will talk about:⁠ - EU MDR transition period extension⁠ - Implementation Rolling Plan⁠ - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746⁠ - Team-NB Position Paper - The designation of notified bodies under the upcoming Artificial Intelligence Act⁠ - Notified Bodies accreditation⁠ - UK Approved bodies⁠ - Training and books⁠ - EU MDCG Guidances⁠ - Swiss and Annex XVI⁠ - US FDA Product codes⁠ - Saudi Arabia Product Classification⁠ - Podcast nostalgia⁠ ⁠ https://podcast.easymedicaldevice.com/213-2/⁠ ⁠ #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/Cm8n2IWM2-Y/?igshid=NGJjMDIxMWI=

BLOG POST⁠ We had a podcast episode on how to set up a cleanroom with Philippe Bourbon from Icare Group and we explained the best way to think of creating a cleanroom.⁠ ⁠ In this blog post, we summarized the different elements discussed and also included more information,⁠ ⁠ Check that here: https://easymedicaldevice.com/cleanroom-for-the-medical-device-industry/⁠ ⁠ #cleanroom #medicaldeviceindustry #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/Cmd8HpzMJtq/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ Since December 9th, 2022 a lot was said about the EU Commission proposal. I have invited Erik Vollebregt to analyze the situation and understand what happened and what will happen.⁠ We will also discuss the MDCG 2022-18 which created a lot of debate after its release.⁠ Listen now to the Medical Device Made Easy Podcast.⁠ ⁠ https://podcast.easymedicaldevice.com/211-2/⁠ ⁠ #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/CmYy9K1saQS/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ Maybe you are part of a new product development and one of the team members asks you: "For this device, which sterilization process we should use per law?". I mean you are Quality/Regulatory affairs so you should know the law ???⁠ You may think now, is there a law that defines which sterilization method to use? Not exactly, but there is a process that is defining which method is suitable or non-suitable for your product. ⁠ ⁠ On this podcast episode, @Jane Scally from @Trinzo will provide you with more details and help also regarding all that is around sterilization.⁠ ⁠ https://podcast.easymedicaldevice.com/208-2⁠ ⁠ #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/Cliv83pszab/?igshid=NGJjMDIxMWI=

PODCAST RELEASE⁠ This item is one of the central information that you should build for your Medical Device. ISO 13485, MDR 2017/745, IVDR 2017/746, MDSAP... everyone asks for it.⁠ ⁠ When you do a Clinical Evaluation you need to know the risks you should evaluate. When you do a Usability, the risks possible should be evaluated in real life. When we talk about cybersecurity, we need to know the risks. As consultants, it is difficult to work on different products as we are not experts on those products, but as soon as we know the risks we can identify the right behavior, standard, and test, the company should perform.⁠ ⁠ In this episode with @Kailash Kalidoss, we will explain to you why Risk Management is important to Medical Device development.⁠ ⁠ https://podcast.easymedicaldevice.com/207-2/⁠ ⁠ #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/ClQyPaOs9Ii/?igshid=NGJjMDIxMWI=

How to place your Medical Device in EU UK and Switzerland if you are located outside of these countries.⁠ ⁠ Check this article that will explain the rules for an EU Authorized Representative or UK responsible person or Importer...⁠ ⁠ https://easymedicaldevice.com/medical-device-eu-uk-switzerland/⁠ ⁠ #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/ClGsDUoMSJJ/?igshid=NGJjMDIxMWI=