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MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling. Read More
Overall reports of adverse events in the UK declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the Medicines and Healthcare products Regulatory Agency. Read More
As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More
Medtronic Navigation of Louisville, Colo., received an FDA Form 483 for issues related to design validation, process validation, CAPAs, acceptance activities and nonconforming product. Read More
All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
Manufacturers should update their medical device tracking procedures to account for unique device identifiers, the FDA says in updated guidance. Read More