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.
Some drug-trial sponsors who used the discredited CRO Cetero Research will need to reanalyze or repeat studies, while others will need to conduct an independent third-party data audit, the FDA told drugmakers in late April. Some luckier sponsors will get a free pass. Sponsors were first notified that work might need to be repeated in July, when the agency revealed that the now infamous CRO violated federal regulations, including falsifying documents and manipulating samples in a number of studies conducted between April 2005 and June 2010. The transgressions threw into question the validity of all of Cetero’s work during that period. Clinical Trials Advisor