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.
St. Jude’s Arecibo, Puerto Rico, facility has fielded a Form 483 because standard operating procedures did not set a deadline for suppliers responding to or completing corrective actions related to supplier corrective action requests. Under the procedure, suppliers may seek extensions for investigations that are still in process. The procedure does not limit the number of extensions a supplier may request, the May 7 Form 483 says. The GMP Letter