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Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Read More
The World Health Organization has published a model regulatory guidance for medical devices and IVDs intended to support developing nations that have yet to develop regulations covering medical devices. 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
Chester, N.Y.-based Repro-Med, a manufacturer of infusion pumps and intravascular administration sets, has earned an FDA warning letter for failures involving quality systems and medical device reporting, as well as other violations. Read More
An FDA warning letter takes SureTek Medical to task for its procedures related to assessing contamination for reprocessed single-use devices. Read More
B. Braun Medical is voluntarily recalling its Dialog+Hemodialysis systems due to fractures in conductivity sensors that may allow air to come in contact with dialysis fluid, leading to poor blood filtration. Read More