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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
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
CDRH: Email Recall Notices Could Pose HIPAA Risks
CDRH: Email Recall Notices Could Pose HIPAA Risks Emailing recall notices to clients may seem efficient, but it could cause a host of concerns around confidentiality and effectiveness, a CDRH official warns. Ronny Brown, chief of the CDRH recall branch, told attendees at FDAnews' 11th Annual Medical Device Quality Congress that while the FDA has been looking at ways to incorporate newer technologies into recall announcements, questions about due diligence remain. . . . more
Commerce Dept. to Provide Key Conflict Mineral Data in September
Commerce Dept. to Provide Key Conflict Mineral Data in September The Department of Commerce plans to submit a list of all known conflict mineral processing facilities to Congress by Sept. 1, according to a new report from the Government Accountability Office. GAO recommends that DOC give Congress a plan, including timeframes, for compiling and reporting the information, which was supposed to be completed by January 2013. . . . more
Smith & Nephew Warned on Recall Notification, GMP Deficiencies
Smith & Nephew Warned on Recall Notification, GMP Deficiencies The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with its Renasys line of negative pressure wound treatment devices. In March 2013, the company distributed a bulletin to users notifying them of changes to the dressing design. The modifications were made after Smith & Nephew found that improper installation of the filter could result in failure to activate the full/blockage alarm, according to the June 11 warning letter published online July 8. The company neither notified the FDA nor provided written justification for not doing so, the letter says. . . . more
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