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.
While drugmakers should not rely on a ‘Plan B’ for validating suppliers, there are some steps they can take if they can’t conduct sufficient quality audits — primarily beefing up incoming acceptance activities, compliance experts say. The FDA generally expects companies to link supplier management with incoming acceptance activities, Denise Dion, vice president of regulatory and quality services at EduQuest and a former agency field inspector, said Wednesday. Drug Industry Daily