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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

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Latest Insights

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

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 to manage PMS trackers, complaint logs, CAPA…

5 min readSep 02, 2026

How TRA Helps Build Safer Healthcare Products

In medical device and pharmaceutical compliance, safety cannot be based on guesswork. Every chemical, residue, impurity, extractable, or leachable has the potential to create risk…

4 min readAug 26, 2026

Toxicological Risk Assessment: Why It Matters

In medical device and pharmaceutical compliance, safety cannot depend on assumptions. It must be supported by strong scientific evidence. This is where Toxicological Risk…

4 min readAug 19, 2026

ISO 10993 Explained for MDR Manufacturers

Biological safety is one of the most important parts of medical device compliance under EU MDR. If a device comes into direct or indirect contact with the human body,…

4 min readAug 12, 2026

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