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.
Thoratec, a world leader in products to treat cardiovascular disease, recently
said that the first major presentation of data from the Phase I trial for its
HeartMate II LVAS (left ventricular assist system) demonstrates encouraging
results in terms of both patient survival and quality of life.