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The FDA cited three devicemakers for a range of deficiencies including inadequate procedures for device failures, MDRs, complaints, and recordkeeping. Read More
Six device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and other procedures. Read More
Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program. Read More