|[December 18, 2013]
Getinge Group: Medical Systems Business Area Enhancing Its Manufacturing Quality Systems Following U.S. FDA Inspections
GETINGE, Sweden --(Business Wire)--
The Medical Systems Business Area of Getinge Group (STO:GETIB) announced
today that, over the past year, a number of its manufacturing facilities
have been inspected by the U.S. Food and Drug Administration (FDA). As a
result of the inspections, as well as its own internal quality
evaluations, Medical Systems is in the process of making significant
improvements to enhance the quality management systems at its
manufacturing facilities around the world.
The FDA inspections generated observations related to the Business
Area's quality management systems and these oservations are being used
to help guide the improvements now underway. Medical Systems is in
discussions with the FDA about these inspectional observations and is
committed to promptly addressing them.
With these improvements, all Medical Systems facilities will have in
place state of the art manufacturing quality systems, and the Business
Area will be well positioned in the future to continue to provide
medical products of the highest quality.
GETINGE GROUP is a leading global medical technology company with
operations in the areas of surgery, intensive care, infection control,
care ergonomics and wound care. The Group is organized into three
business areas: Extended Care, Infection Control and Medical Systems,
and operates under the ArjoHuntleigh, GETINGE and MAQUET brands.
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