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Utah Medical Products, Inc. is dedicated to the
development and manufacture of the safest and most effective medical
devices possible. Our quality systems are structured and managed with
this goal in mind.
The result - devices used hundreds of thousands of times annually
over many years in high risk critical care situations with an extremely
low frequency of complaints. See our Quality
Systems Information Sheet
It is the mission of Utah Medical Products, Inc.® (UTMD) and its subsidiaries to provide consistently high quality products that perform at or beyond customers' needs and expectations. This objective is the driving force behind UTMD's business. We are committed to continuous quality improvement and take pride in effectively responding to customers' needs by:
Continuously
improving all aspects of our business.
Improving
communication with our customers through product definition, design
and problem solving.
| Quality Systems Information Sheet | ||
| NAME: | Utah Medical Products, Inc. | |
| ADDRESS: | 7043 South 300 West | |
| CITY/STATE/ZIP: | Midvale, Utah 84047 | |
| PHONE #: | (801) 566-1200 | |
| FAX #: | (801) 566-2062 | |
| PRIMARY MANAGEMENT: | NAME |
TITLE |
| Kevin L. Cornwell | CEO | |
| Ben Shirley | VP, R&D and Quality Assurance | |
| Jean Teasdale | VP, Manufacturing | |
| ITEMS CURRENTLY MANUFACTURED: | OB/GYN, Neonatology, Electrosurgery and Blood Pressure Monitoring. | |
| APPROXIMATE NUMBER OF EMPLOYEES: | 200 | |
| FACILITIES (UTAH, OREGON, IRELAND) |
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| Approx. Square Feet: | 180,000 sq. ft | |
| Business Start-Up: | April 1978(UT), November 1996(IRE) | |
| NUMBER OF SHIFTS: | 2 Assembly, 3 Molding | |
| FDA REGISTRATION #: | 1718873 | |
| FEDERAL TAX ID #: | 87-0342734 | |
| ISO 13485 CERTIFIED?: | Yes, view & print certificate: ISO 13485:2003 (pdf) | |
| IN COMPLIANCE WITH cGMP/QSR?: | Yes | |
| QUALITY MANUAL?: | Yes | |
| LOT # SYSTEM: | XYYZZZZ = X (Mfg. Location), YY (Last Two Digits of Year Mfg.), ZZZZ (Sequentially Assigned) | |
| HOW IS LOT/BATCH DEFINED?: | Lot #, Serial # | |
| All documents are issued and maintained through a formal review process and a change request system. Document Control maintains device master records. | ||