The EU General Data Protection Regulation (GDPR) text has been finalized and the regulation will enter into force soon, setting the legal framework for processing of personal data in the EU for the coming decades. Read more Invitation & Program
After having contributed to the improvement of medical devices legislation in many ways over the years (most recently by helping the European Parliament to come up with an initiative for targeted amendments…
The MDR and IVDR are now in force for seven (7) years, and they are not in good shape. I think it is safe to say that they did not deliver on…
Sometimes you come across cases that violate Mandalorian Creed: “One does not speak unless one knows.”. This happened to me last week when I read the Dutch Supreme Court’s judgment in a…