Resources

This section features expert content on medical device regulations, RegTech approaches, and R&D strategies.

11.03.2026 - Most medical device manufacturers in Turkey still use Excel for risk management.

But is this approach sustainable in the age of the MDR?

In my article, I analyzed the following question:

Why is RegTech no longer just a quality tool but is becoming a strategic infrastructure in the medical sector?

17.03.2026 - A medical device manufacturer in Turkey holds ISO 13485 certification.

However, in the post-MDR environment, the following question is becoming increasingly critical:

"Does being certified truly mean sustainable compliance?"

Observations in the field indicate the following:

The issue is not a lack of knowledge about regulations, but an inability to sustainably manage the

requirements-risk-testing-change-PMS chain

In this new article, the RegTech maturity level of manufacturers in Turkey and the regulatory tipping point

post-TRL are analyzed.

The article covers the following topics:

25.03.2026 - Is the technical file still just a folder? Or is it a system?

👉 How does the technical file transform into a closed-loop regulatory system?
(Field data → Risk → Design → Testing → back to market)

📊 And the most critical prediction:
👉 The technical file is no longer an "output"
👉 A "core system" that manages the product lifecycle

🎯 If you're still:
• Using Excel + Word + folders
• The Requirement–Risk–Test link is broken
• PMS data isn't feeding back into the technical file

➡️ This isn't just an operational problem; A strategic regulatory risk