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.
A Form 483 for AngioDynamics of Queensbury, N.Y., states the company distributed a range of devices with flaws or unapproved features. The 12-observation Form 483 was issued at the conclusion of an inspection that stretched from Nov. 14, 2011, to Feb. 10 of this year. For example, the FDA had informed AngioDynamics that a soft tissue ablation tool made by the company could only be cleared if one feature was removed. The company removed the feature but allowed previously distributed products to remain on the market with the feature intact. In another instance, the company discovered during a premarket visual inspection that there was a hairline crack in the sheath of an infusion system but allowed it to go to market. The GMP Letter