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As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More
Medtronic Ireland failed to submit MDR reports within 30 days of becoming aware of an event, including two that involved the death of a patient, according to a May 15 Form 483, recently released. Read More
Terumo BCT has received a Form 483 citing manufacturing problems with incoming product acceptance and environmental controls on its blood collection systems. Read More
Western Enterprises/Scott Fetzer Company received an FDA warning letter after averaging its suppliers’ quality ratings with its delivery ratings, resulting in a higher overall rating for some suppliers. Read More