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Why Your CER Needs More Than a Literature Review

Your medical device has a 95% success rate. Sounds impressive, right? But what if similar technologies routinely achieve 99%? Suddenly, that 95% tells a very different story. This…

4 min readNov 04, 2026

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Latest Insights

When Clinical Claims Go Beyond the Evidence

Your medical device works. Your test results look promising. Your marketing claims sound impressive. But what happens when a Notified Body asks: “Where is the clinical evidence…

4 min readOct 28, 2026

Clinical Evidence Gap Analysis: What Are You Missing?

Clinical Evidence Gap Analysis is essential before preparing a Clinical Evaluation Report (CER) under EU MDR. Many medical device manufacturers face Notified Body questions…

6 min readOct 21, 2026

CER Deficiencies That Trigger Notified Body Questions

CER deficiencies are one of the main reasons Clinical Evaluation Reports receive Notified Body questions under EU MDR. Many CERs fail review not because clinical data is missing,…

7 min readOct 14, 2026

VigiX360 Clinical Evidence Platform for Global Workflows

Clinical and regulatory work is becoming more connected than ever. A protocol may change, but the data collection forms may still reflect the previous version. A reviewer may ask…

5 min readOct 08, 2026

EU MDR & IVDR 2026 Updates for Manufacturers

The European medical device regulatory landscape is changing fast. For manufacturers working under EU MDR and EU IVDR, compliance in 2026 is no longer just about holding a CE…

6 min readOct 07, 2026

Performance Evaluation Under IVDR Explained

Performance evaluation is one of the most important requirements for IVD manufacturers under the EU IVDR. Under the In Vitro Diagnostic Medical Devices Regulation, manufacturers…

4 min readSep 23, 2026

Why Spreadsheets Break Down During MDR Audits

Spreadsheets are simple. They are familiar. They are easy to start with. That is why many medical device companies still use them for PMS tracking, complaint logs, CAPA actions,…

5 min readSep 16, 2026

What Is Permitted Daily Exposure (PDE)?

In pharmaceutical and medical device manufacturing, patient safety does not end with the final product. It also depends on how well manufacturers control residues, impurities,…

4 min readSep 09, 2026

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