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The Association for the Advancement of Medical Instrumentation (AAMI) has developed a newÂ benchmarking tool to help medical device designers and manufacturers determineÂ how their quality management systems (QMS) compare with that of their peerÂ companies, just as the Food and Drug Administration (FDA) increases its focusÂ on quality.
A free online demonstration of AAMIs new benchmarking platform will be held on Wednesday, Oct. 30, 2013 atÂ 3 p.m. Medical device designers and manufacturers can register for the free online demo by clicking this link and entering their contact information.
In recognition of a new FDA emphasis on promoting device quality, andÂ not simply regulatory compliance, AAMI has created BenchmarkingÂ SolutionsQuality Management System for Medical Devices. The resource isÂ designed to help medical device quality system professionals compare theirÂ organizations QMS policies, processes, procedures, and performance metricsÂ against those of other organizations in the field. The tool also can be used byÂ a company to benchmark its different manufacturing facilities and operations.Â This is AAMIs third online benchmarking tool; the other two are targeted atÂ the healthcare technology management (HTM) and sterile processing communities.
ThroughÂ the new program, companies subscribe annually to anonymously enter their dataÂ into an online survey. They can update and revise their data at any pointÂ during the year.
Initially,Â the tool will feature in-depth questions on two important QMS processesCAPAÂ and risk managementand will expand into other quality system processes in theÂ future. The benchmarking questions for the two QMS processes were developed byÂ a team of eight subject matter experts. A steering committee that oversaw theÂ development of the benchmarking tool included representatives from the FDA,Â industry, AdvaMed, and Dynamic BenchmarkingAAMIs software developer thatÂ produced all three of the benchmarking programs. The work of the experts andÂ the steering committee was facilitated by Ed Kimmelman, QMS technicalÂ consultant to AAMI and convenor of the ISO/TC210, WG1, the developer of ISOÂ 13485:2003.
AfterÂ answering the questions on risk management and CAPA, a subscriber can compareÂ its results against other manufacturers based on organization size, complexity,Â market focus, and other criteria. Output results are displayed using simple,Â intuitive charts and graphs, which can be customized for internalÂ presentations.
AAMIÂ plans to expand the benchmarking tool each year with additional QMS processÂ areas (e.g., design and development, process validation). A BenchmarkingÂ Advisory Task Force will review recommendations from subscribers and also makeÂ its own suggestions for improvement. Members of AAMIs staff will review theÂ task forces recommendations.
For aÂ single organization, a new one-year subscription is $1,100 for AAMI members andÂ $1,450 for nonmembers. The results only option, intended for consultants andÂ others who want to view aggregate benchmarking data but dont have any of theirÂ own to enter, will cost members $2,200. The list price is $2,700.
Source: Association for the Advancement of Medical Instrumentation