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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

03/02/2026

That’s how you leave the competition watching... 👀 Easy Medical Device makes compliance simple.

02/02/2026

QSR vs QMSR — Understanding the Differences

FDA inspections are evolving, and the shift from QSR to QMSR brings more than a name change.

𝗤𝗦𝗥 (𝟮𝟭 𝗖𝗙𝗥 𝗣𝗮𝗿𝘁 𝟴𝟮𝟬)

• Procedural and checklist-driven
• Focused on documents and SOPs
• Audits centered on isolated records like CAPA, complaints, or design controls
• Created a US-specific quality culture

𝗤𝗠𝗦𝗥 (𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗦𝘆𝘀𝘁𝗲𝗺 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻)

• Process-based and end-to-end
• Risk is integrated across all processes, not just R&D or CAPA
• Lifecycle-oriented: inspections follow products, processes, and risks as a connected system
• Harmonized with ISO 13485 for global consistency

The key shift is philosophical: FDA inspections now focus on how processes actually work together, rather than just verifying that procedures exist.

28/01/2026

When your device is ready, but both the EU and US want a piece of you…

26/01/2026

DHF remediation isn’t a documentation task — it’s a business-critical transformation.

Without the right structure, 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 𝗿𝗶𝘀𝗸:
• Delays to market
• Regulatory escalation
• Product safety issues
• Repeat nonconformities

The right 𝗰𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝗵𝗲𝗹𝗽𝘀 𝘆𝗼𝘂:
• Assess real compliance gaps
• Build a remediation strategy
• Execute with cross-functional alignment
• Validate readiness before inspections

This is how remediation becomes a long-term strength — not just a short-term fix.

21/01/2026

This escalated very quickly 🙃 — Easy Medical Device makes it easier.

19/01/2026

𝗦𝗮𝗠𝗗 𝘀𝗮𝗳𝗲𝘁𝘆 𝗶𝘀 𝗻𝗼𝘁 𝗼𝗻𝗲 𝘁𝗵𝗶𝗻𝗴 — 𝗶𝘁’𝘀 𝘁𝗵𝗿𝗲𝗲 𝘄𝗼𝗿𝗸𝗶𝗻𝗴 𝘁𝗼𝗴𝗲𝘁𝗵𝗲𝗿.

Software as a Medical Device risk management stands on three pillars:

• 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗦𝗮𝗳𝗲𝘁𝘆 — Ensuring outputs lead to correct medical decisions
• 𝗖𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 — Protecting systems from misuse, attacks, and data manipulation
• 𝗨𝘀𝗮𝗯𝗶𝗹𝗶𝘁𝘆 — Preventing use errors and misinterpretation by users

Ignore one — and patient safety is compromised.

Risk management isn’t a document.
It’s a system — designed, controlled, and continuously monitored.

14/01/2026

So… that’s how Rule 11 starts 🙃

12/01/2026

Clinical Evaluation serves two purposes at the same time.

🧠 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐫𝐞𝐚𝐥𝐢𝐭𝐲
It must demonstrate that the device works as intended and is safe in real-world use.

📜 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐫𝐞𝐚𝐥𝐢𝐭𝐲
It must translate that clinical evidence into conclusions that meet EU MDR expectations.

These two logics are different — and both are mandatory.

A device can perform well clinically, yet fail to obtain CE marking if the evidence is not structured, justified, and acceptable under MDR.

Likewise, a perfectly formatted report fails if it does not reflect real clinical practice.

Under EU MDR, the Clinical Evaluation is the document that connects science, clinical use, and regulatory decision-making.

Fail either side, and CE marking is not granted.

hashtag hashtag hashtag hashtag

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.

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

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

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