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AAMI Develops Benchmarking Tool to Help Device Manufacturers Compare Quality Management Systems

The Association for the Advancement of Medical Instrumentation (AAMI) has developed a new  benchmarking tool to help medical device designers and manufacturers determine how their quality management systems (QMS) compare with that of their peer companies, just as the Food and Drug Administration (FDA) increases its focus  on quality.

A free online demonstration of AAMI’s new benchmarking platform will be held on Wednesday, Oct. 30, 2013 at 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, and  not simply regulatory compliance, AAMI has created Benchmarking  Solutions—Quality Management System for Medical Devices. The resource is  designed to help medical device quality system professionals compare their  organizations’ QMS policies, processes, procedures, and performance metrics  against those of other organizations in the field. The tool also can be used by  a company to benchmark its different manufacturing facilities and operations.  This is AAMI’s third online benchmarking tool; the other two are targeted at  the healthcare technology management (HTM) and sterile processing communities.

Through  the new program, companies subscribe annually to anonymously enter their data  into an online survey. They can update and revise their data at any point  during the year.
Initially,  the tool will feature in-depth questions on two important QMS processes—CAPA  and risk management—and will expand into other quality system processes in the  future. The benchmarking questions for the two QMS processes were developed by  a team of eight subject matter experts. A steering committee that oversaw the  development of the benchmarking tool included representatives from the FDA,  industry, AdvaMed, and Dynamic Benchmarking—AAMI’s software developer that  produced all three of the benchmarking programs. The work of the experts and  the steering committee was facilitated by Ed Kimmelman, QMS technical  consultant to AAMI and convenor of the ISO/TC210, WG1, the developer of ISO  13485:2003.

After  answering the questions on risk management and CAPA, a subscriber can compare  its results against other manufacturers based on organization size, complexity,  market focus, and other criteria. Output results are displayed using simple,  intuitive charts and graphs, which can be customized for internal  presentations.

AAMI plans to expand the benchmarking tool each year with additional QMS process  areas (e.g., design and development, process validation). A Benchmarking  Advisory Task Force will review recommendations from subscribers and also make  its own suggestions for improvement. Members of AAMI’s staff will review the  task force’s recommendations.
For a  single organization, a new one-year subscription is $1,100 for AAMI members and  $1,450 for nonmembers. The “results only” option, intended for consultants and  others who want to view aggregate benchmarking data but don’t have any of their  own to enter, will cost members $2,200. The list price is $2,700.

Source: Association for the Advancement of Medical Instrumentation

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