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The FDA has clarified expectations on unique device identifiers, which must appear in two forms on device labels and packages: an easily readable plain-text form and an automatic identification and data capture technology form. Read More
The EU’s new medical device regulations will have far-reaching implications for manufacturing and supply chain operations, and the least of which are increased roles and oversight from notified bodies that will directly impact quality management systems. Read More
The FDA found process validation, medical device reporting and other quality system failures at Biotronik’s Berlin facility during a recent inspection. Read More
Japan’s Mitaka Kohki failed to establish design control procedures, CAPA procedures, equipment calibration procedures, and documentation was found lacking for numerous critical processes during an inspection of the Tokyo-based facility. Read More
TriMed, a maker of implantable bone fixation systems, failed to report a device failure that required surgery to remove the device, according to an FDA warning letter. Read More
Vancouver-based RS Medical was handed a 483 following a February inspection that found CAPA procedures and validation activities lacking. The company manufactures electrotherapy pain products. Read More
Failure to control its production processes and to validate them properly landed devicemaker Oscor an FDA warning letter for quality system deficiencies. 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