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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

Expert: Get Documentation in Order as UDI Deadline Approaches
Expert: Get Documentation in Order as UDI Deadline Approaches With FDA investigators soon to begin scrutinizing UDI compliance, Class III devicemakers should prepare by ensuring that UDI changes in design history files are adequately documented and that the company has a verification process for barcodes in place. The deadline for Class III devices to display a unique device identifier is Sept. 24, and after that FDA investigators will likely treat the new requirements as they would any other kind of quality system activity, with inspectors seeking good documentation of how a device will be marked and at what level, says Jay Crowley, UDI practice lead for USDM and former senior safety advisor and UDI architect at the FDA. . . . more
Audit Procedure, ‘Backup Employees’ Good Prep for Unannounced Audits
Audit Procedure, ‘Backup Employees’ Good Prep for Unannounced Audits 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 unannounced audits required by the European Commission. Having more than one point person will allow companies to successfully handle an unannounced audit even if their main contact is sick or on vacation, says Richard Vincins, vice president of quality assurance consulting at Emergo Group. . . . more
Iradimed Warned Over CAPAs, Procedures
Iradimed Warned Over CAPAs, Procedures The FDA has warned Winter Park, Fla., devicemaker Iradimed for failing to initiate and validate corrective actions related to its infusion pumps and sets. Among the concerns cited by the agency, the company had recalled some of its infusion sets after finding a tubing segment was too long, which could cause them to over-infuse, and traced the root cause to production process controls at its contract manufacturer. . . . more
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
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