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.
CDRH plans to roll out 12 final guidance documents in fiscal 2014, including guidances on cybersecurity, the device appeals process and the global unique device identification database, or GUDID, the center revealed Thursday. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More