It’s that time again. Friday’s the chance to review the week just gone. This week it’s been Heart Rhythm 2012, so there’s plenty to chew on as the controversies and indeed the advances keep coming.
editorial
Cranberry Tablet Stretches Definition Of A Medical Device
You say potato, I say prosthesis. While somehow a therapeutic cranberry capsule has uniquely found its way to market as a medical device, we’re scratching our heads about the whole affair.
Does FDA Missing Four Devices Help Guide Future Regulatory Rules?
We can’t even harmonise the spelling of the word harmonize, so what chance of bringing our regulatory processes closer together?
Medtech Regulatory Affairs: Is It Time For More Transparency In Europe?
US regulatory agency the FDA issues very public warning letters to companies which are then trotted out around the media so we can all revel in the organisations pain. But would this level of openness be well received in Europe where medical device regulations seem to be in the media’s crosshairs too frequently for the industry’s own good.
CE Marked… But On What Clinical Evidence?
We get really really fed up with medical device companies trotting out lightweight press releases about newly CE marked products, like we’re all going to say “great” and rush out to use them. This is a plea to companies to provide their evidence and let us decide whether it passes muster.
So, are we getting it right?
Medlatest seeks to be end-user focused and international. We’re asking you if we’re hitting the spot.