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 bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year.
To comply with FDA’s combination product good manufacturing practices, both devicemakers and drugmakers should first look at their systems and conduct a gap analysis using both the quality system regulation and drug cGMPs. Read More
Following more than 5,000 complaints including reports of patient injuries and four deaths, the FDA is taking a second look at the safety and effectiveness of Bayer’s Essure birth control implant. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has successfully prosecuted two companies it says supplied defective prefilled syringes whose use resulted in a diabetic patient’s death in 2010. Read More
Inadequate investigations and corrective and preventive actions have been one of the top reasons for 483 observations since 1997, says James Vesper, president of LearningPlus. A 30-year veteran in the lifesciences business, Vesper talked with FDAnews about how to develop a successful CAPA program to uncover root causes of quality failures.Read More