The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
World Heart Corporation, a global technology leader in mechanical circulatory
support systems, today announced that its next-generation pulsatile left ventricular
assist system ("LVAS"), the Novacor II, has entered a key phase of
animal testing on the development pathway toward human trials.