Full Press Release Details
City, Utah - Utah Medical Products, Inc. (Nasdaq: UTMD) announces that on
November 3, 2005 it concluded an annual surveillance audit to maintain its
registration to ISO 13485, a set of well-accepted international quality
standards for medical device manufacturers. The audit was conducted by the
National Standards Authority of Ireland (NSAI), an independent registrar.
lead auditor recommended that UTMD maintain registration to CAN/CSA ISO
"Outcome of the Audit" section, the lead auditor wrote, "The organization [UTMD]
should be commended for their dedication to compliance to the MDD (Medical
Device Directive) and CMDR (Canadian Medical Device Directive)."
"Summary and Conclusion" section, the lead auditor wrote, "The documented
[quality] system is functioning well," and "Overall, the management system is
meeting the expectations of the Standard under assessment."
auditor was the same person who led the NSAI surveillance audit in November
2004, which followed UTMD's 2003 conversion from the ISO 9001 EN 46001 standard
to the more rigorous medical device ISO 13485 standard.
Medical Products, Inc., with particular interest in health care for women
their babies, develops, manufactures, assembles and markets a broad range
disposable and reusable specialty medical devices.