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.
The agency said the testimonials do not “adequately support the suggestion in the presentation that other patients switching to Livalo from other statins will experience a similar reduction in side effects.”
The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium. Read More
Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis. Read More