Insights

Practical guides on medical device regulation, quality systems and good distribution practice in Belgium, written for the people who have to act on them. Every guide is reviewed by Hendrik Staels.

Medical devices11 November 20267 min read

EUDAMED registration in 2026: who needs to do what?

EUDAMED has been mandatory since 28 May 2026. This guide sets out, by role, what to register, for which devices and by when.

Read the guide Reviewed by Hendrik

Quality systems11 November 2026

ISO 9001:2026: what medical device distributors should review

ISO 9001:2026 is published and the transition runs until 30 September 2029. Here is how a medical device distributor prepares its review.6 min read Distribution (GDP)11 November 2026

GDP training for Responsible Persons: requirements and evidence

What good distribution practice expects from training, how a Responsible Person keeps their competence current and which records show it.7 min read

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