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MedDeviceSupplyChain.com is the premier source for information and practical advice about supply chain quality issues for medical device manufacturers. We provide the latest news and guidance for building and maintaining a supplier quality management program that satisfies the latest global regulatory quality requirements.


FEATURED ARTICLES
FDA Not Specifying Data Capture Tech for UDI, FAQ Guidance Says
FDA Not Specifying Data Capture Tech for UDI, FAQ Guidance Says 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. The agency is not specifying what AIDC technologies should be used, "because the most appropriate technology will vary considerably depending on the type of device and its intended uses," the guidance says. The FDA also notes that technologies are likely to change over time. . . . more
FDA Issues UDI Compliance Doc Designed to Help Small Entities
FDA Issues UDI Compliance Doc Designed to Help Small Entities 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 next month. The final guidance, issued Aug. 13, provides an overview of UDI regulatory requirements and explains steps companies should take to comply, but doesn't contain any changes to existing policy. . . . more
FDA to Spacelabs: Get Consultant to Audit on CAPA, MDR Issues
FDA to Spacelabs: Get Consultant to Audit on CAPA, MDR Issues The FDA has asked Spacelabs Healthcare, a maker of patient monitoring devices, to get an audit from an outside consultant to address problems with corrective and preventive actions and MDRs. The Aug. 11 warning letter, posted online Aug. 19, requests initial certifications from the consultant and from Spacelab's CEO by Jan. 4, and any subsequent certifications for updated audits by Aug. 4, 2015, and Aug. 4, 2016. During the Feb. 12 to April 2 inspection of the company's Snoqualmie, Wash., facility, the FDA found that several CAPAs were closed without implementing the corrective actions. . . . more
Careful Risk Management Needed To Conform to MDD, Annexes Z
Careful Risk Management Needed To Conform to MDD, Annexes Z 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. "In any case, the manufacturer shall perform an overall risk-benefit analysis considering all individual risks to provide a rationale for overall risk acceptance," the draft says. Compliance will be determined by inspections of both individual and overall risk-benefit analyses. . . . more
FDA Slaps Ventlab With Warning For Nonconforming Material Issues
FDA Slaps Ventlab With Warning For Nonconforming Material Issues Ventlab has received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components. A supplier to the Grand Rapids, Mich., company failed to inform Ventlab that it did not conform to requirements for washing, drying and lubricating duckbill valves, according to the July 2 warning letter posted online Tuesday. . . . more
CareFusion Warned Over Handling of Debris and Particulate Matter
CareFusion Warned Over Handling of Debris and Particulate Matter CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. The company's corrective and preventive action investigation should have identified the material and determined its source, according to the June 6 letter posted online Tuesday. The devicemaker was aware of complaints about debris and particulate matter with its Denver Ascites Shunt and Percutaneous Access Kit with Ascites Shunt since August 2011, the letter says. . . . more
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