,
Erik Vollebregt
This seminar addressed the review of the regulatory requirements for clinical trials. Speakers and their presentations: Joris Bannenberg, Factory-CRO Developments in Clinical Trials for Medical Devices Erik Vollebregt, Axon Lawyers Clinical Trial…
,
Erik Vollebregt
After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you…
,
Erik Vollebregt
We had the first reading vote by the European Parliament on 2 April. Let’s put it in perspective. The previous last important iterations in the legislative process are the EP’s plenary vote on…
,
Erik Vollebregt
A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between…
,
Erik Vollebregt
This spring holiday I took the recently published Study on Corruption in the Healthcare Sector with me as holiday reading and that proved a good choice. The 332 pages long study was commissioned…
,
Karin Verzijden
After a succesful Autumn College last year September, this 2 days event on EU Food Law is repeated under the name Spring College. The event will take place on 27 and 28…
,
Erik Vollebregt
Lately I have thought a lot about future-proofing of the new EU regulation proposals for medical devices and IVDs, specifically with respect to the development of 3D printing of individualized (custom) medical…
,
Karin Verzijden
Dutch slaughterhouse Van Hattem suffering severe blow This week the Trade and Industry Appeals Tribunal, (in Dutch: College van Beroep voor het bedrijfsleven) rendered its judgment (interim injunction) in the lawsuit that…