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The FDA has published a unique device identification compliance guide aimed at helping small manufacturers prepare for UDI implementation, the first stage of which comes due in September. Read More
The FDA has warned Masimo’s Irvine, Calif., facility over complaint issues, failure to establish and maintain procedures for implementing corrective and preventive action, and failure to investigate the causes of nonconformities. Read More
Devicemakers in the EU need to make sure they have at least two or three employees who are prepared to handle an audit, as notified bodies begin conducting the unannounced audits required by the European Commission. Read More
Manufacturers implementing unique device identification may choose a barcode for their Automatic Identification Data Capture technology, or they can use “any other technology that serves the same objectives,” new FDA guidance clarifies. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
Before manufacturers complete their risk-management processes, they should perform a risk-benefit analysis for any risks that are unacceptable under Annexes Z in EN ISO 14971: 2012, and for which further risk reduction is possible, according to a draft consensus paper from the EU-based Notified Body Recommendation Group.
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The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
Ventlab received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components. Read More
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More