At Advamed’s San Jose MedTech Conference this year it was quite a surprise for me to see how many US companies are still not doing what is necessary to become compliant with the MDR and the IVDR in time. In the EU MDR session at that conference about 5% of the audience raised their hand […]
Sometimes you have days that you feel like Cassandra. I had a Cassandra moment after moderating the MDR panel at the Advamed MedTech Conference on 25 September. Cassandra was a lady from mythological heritage. She made the Greek god Apollo angry by changing her mind to be his girlfriend after he had granted her the […]
This is not a substantive post, just a note to say that I am visiting the RAPS Regulatory Convergence conference in Austin next week and then the Advamed MedTech conference in Chicago in the week after that. RAPS conference I will speak about the emerging EU UDI policy at the RAPS Regulatory Convergence conference on […]