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Easy Medical Device

Easy Medical Device is a Web blog to learn everything on Medical Devices Regulation. How to market a

09/01/2026

𝐑𝐞𝐦𝐢𝐧𝐝𝐞𝐫 | 𝐄𝐌𝐃 𝐌𝐚𝐠 – 𝐈𝐬𝐬𝐮𝐞 3 𝐢𝐬 𝐎𝐮𝐭 🔔

Regulatory changes don’t slow down—and guessing what matters can put your compliance at risk.

EMD Mag – Issue 3 is out to help you quickly understand what’s changing, what’s coming next, and how it impacts your MedTech work—without wasting time on noise.

With this issue, you will:

● Understand what the new EU MDR & IVDR proposal really means and what to monitor next
● Anticipate potential impact from the ISO 18969 draft before it becomes final
● Stay ahead of the most important regulatory updates for 2026
● Know when and why EUDAMED becomes mandatory
● Identify key risks and expectations for CGM devices
● Learn when Article 61(10) can (and cannot) be used, especially for software
● See how to move toward a digital eQMS with clarity
● Recharge with a chill corner and plan your upcoming conferences

One issue. Clear insights. Better decisions.

Get the 𝐟𝐫𝐞𝐞 𝐄𝐌𝐃 𝐌𝐚𝐠𝐚𝐳𝐢𝐧 now:
➡️ https://mailchi.mp/easymedicaldevice/emd-mag-issue-3

18/12/2025

Get inspired by the journey of Florian Tolkmitt 🤯 - https://mailchi.mp/40717dac0554/get-inspired-by-the-journey-of-florian-tolkmitt-17999153

04/12/2025

Check how to become a LEAD AUDITOR 🤯 - https://mailchi.mp/d06caf7d249e/check-how-to-become-a-lead-auditor-17998832

22/05/2025

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification. So stay tuned.

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Check this here https://podcast.easymedicaldevice.com/337-2/

15/05/2025

🎙️𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode.

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Check this here. https://podcast.easymedicaldevice.com/336-2/

08/05/2025

🎙️𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything, and they need this person to take care of the registration before launch. But this is wrong, and we’ll let you know when and why you should involve them earlier. Listen to this episode.

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Check this here. https://podcast.easymedicaldevice.com/335-2/

01/05/2025

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode. So stay tuned.

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Check this here. https://podcast.easymedicaldevice.com/334-2/

24/04/2025

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. You will see in this episode that some elements will be similar to registration in EU or US but you will also see a lot of differences. We will also talk about cost for the registration and you will see how this is affordable. So stay tuned.

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Check this here https://podcast.easymedicaldevice.com/333-2/

17/04/2025

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. You will see within this episode that this is not something made for everyone, so you really need to listen to this to understand if this is the right decision for you. So stay tuned.

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Check this here: https://podcast.easymedicaldevice.com/332-2/

10/04/2025

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA. So stay tuned.

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Check this here https://podcast.easymedicaldevice.com/331-2/

27/03/2025

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics. So stay tuned.

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Check this here https://podcast.easymedicaldevice.com/329-2/

20/03/2025

🎙️ 𝐏𝐎𝐃𝐂𝐀𝐒𝐓 𝐑𝐄𝐋𝐄𝐀𝐒𝐄 🎙️

In this episode, Darrin Carlson will explain to us what are the main issues that are discovered during FDA inspections and how to correct them. We will also explain the different between an FDA inspection and a Notified Body audit. So stay tuned.

Share this with your contacts if you know someone that would benefit from it.

Check this here https://podcast.easymedicaldevice.com/328-2/

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