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View previous topic :: View next topic   Author Message GaryW Site Admin Joined: 14 Oct 2005 Posts: 106530 Location: Adelaide, Australia Posted: Wed Sep 08, 2010 6:48 am    Post subject: FDA grants Teleflex 510(k) clearance for ArrowEVOLUTION PICC with Chlorag+ard technology Teleflex Incorporated today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the company's ArrowEVOLUTIONâ„¢ PICC with Chlorag+ardâ„¢ technology, a peripherally inserted central catheter with a Chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and extralumenally. Teleflex will launch the product for general availability in the United States in the fourth quarter. [url=http://www.news-medical.net/news/20100907/FDA-grants-Teleflex-510(k)-clearance-for-ArrowEVOLUTION-PICC-with-Chlorag2bard-technology.aspx]Read more...[/url] Source: THE MEDICAL NEWS from News-Medical.Net - Latest Medical News and Research from Around the World _________________ Regards, Gary Wilkinson Founder & Principal Consultant SQR Consulting Back to top Display posts from previous: All Posts1 Day7 Days2 Weeks1 Month3 Months6 Months1 Year Oldest FirstNewest First            strategic-quality-resources.com Forum Index -> Medical/Pharmaceutical All times are GMT + 9.5 Hours Page 1 of 1   Jump to: Select a forum General News and Administration----------------Announcements-- Changes to the SQR Forums-- Changes to the SQR Web Site-- Our Admin/Moderators-- Our RSS FeedsAround the Water CoolerQuality News Business Excellence Models/Awards----------------Australian Business Excellence Framework (ABEF)Capability Maturity Model Integration (CMMI)European Foundation for Quality Management (EFQM) Business Excellence ModelMalcolm Baldrige National Quality Award (MBNQA) Management Systems----------------Business Process Management (BPM)-- Process MappingEnvironmental Management Systems-- Hazmat Management SystemsIntegrated Management Systems (IMS)Information Security Management Systems (ISMS)-- Latest Virus/IT VulnerabilitiesDocument/Record Management Systems (D/RMS)-- Digital Rights Management (DRM)-- PDF Document InformationCustomer Relationship Management (CRM)Food Safety Management Systems-- HACCPStrategic Quality Management (SQM)Supply Change Management (SCM) and Logistics Miscellaneous Industry Specific Standards and Practices----------------Automotive-- ISO/TS 16949Aerospace-- SAE AS9100-- SAE AS9110-- SAE AS9120Medical/Pharmaceutical-- Good Clinical Practice (GCP)-- Good Manufacturing Practice (GMP)-- Food and Drug Administration (FDA)-- General Clinical Trials-- International Conference on Harmonisation (ICH)Defence/Military Industries National and International Management Standards----------------Environmental Management System Standard - ISO 14001 Family-- ISO 14001-- ISO 14004Food Safety Management System Standard - ISO 22000 Family-- ISO 22000-- ISO/TS 22004Information technology – Security techniques ISO /IEC 27001Medical Devices Management System Standard - ISO 13485-- Medical Devices - General NewsOccupational Health and Safety Family-- AS/NZS 4801-- AS/NZS 4804-- ISO 18001Quality Management System Standard - ISO 9001 Family-- ISO 9000-- ISO 9001-- ISO/IEC 90003-- ISO 9004 Organisational Development and Business Continuity----------------Business InnovationChange ManagementContingency Crisis Management-- Business Continuity Planning-- Crisis Management-- Regulatory Incident Reporting and Investigation-- Workplace Emergency PlanningKnowledge Management & Business Intelligence-- Data Management & Data Mining-- KM StandardsHuman Resources-- Outsourcing-- Careers and JobsLeadership and ManagementHuman Factors and ErgonomicsRisk Management-- AS/NZS 4360Social ResponsibilityTraining and Professional DevelopmentStrategic Analysis & Direction Systems/Software Development Methodologies----------------Configuration Management (CM)DOD-STD-2167A - Defense System Software DevelopmentIntegrated Product Teams (IPT)MIL-STD-498 - Software Development and DocumentationGeneral Systems/Software NewsSoftware Quality Assurance (SQA) Tools and Techniques----------------Balanced ScorecardBenchmarkingConducting Audits-- Environmental Audits-- Quality Audits-- Safety AuditsSelf Directed Work TeamsSix SigmaStatistical Process Control (SPC)Process Mapping Software Total Quality Management (TQM)----------------Total Quality Management (TQM)TQM Gurus-- W. Edwards Deming-- Joseph Juran-- Philip Crosby  You cannot post new topics in this forum You cannot reply to topics in this forum You cannot edit your posts in this forum You cannot delete your posts in this forum You cannot vote in polls in this forum You cannot attach files in this forum You cannot download files in this forum

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