For the benefit of the clinicians and patients who rely on our specialized products, we will continue to consistently research, develop and manufacture innovative medical devices that can be counted on to convey predictable clinical results.
To achieve this goal we must also seek to produce the highest quality products possible, and by every measure of quality, we have been successful and will continue to be successful.
Utah
Medical Products, Inc.® is focused on the discovery and development
of high-quality, cost-effective medical devices that solve clinical
needs and improve patient outcomes across all our areas of specialization
including: perinatology, neonatology, gynecology, electrosurgery,
urology, blood pressure monitoring and blood management.
Our R&D investment includes the costs of:
developing
innovative concepts.
testing
concepts for viability.
validating
methods of manufacture.
completing
premarket regulatory activities required for design control.
responding
to customer requests for product enhancements.
assisting
manufacturing in developing new processes or improving existing processes.
In addition to internal development, Utah Medical is committed to the opportunistic aquisition of external sources of new product concepts that fit into our product development strategy and continue to actively seek out these opportunities.
With a strong commitment to science and innovation, Utah Medical Products, Inc.® continues to pursue its most important R&D vision of developing medical devices that ultimately help save lives.
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.
Involving
all employees in quality system efforts.
| 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, IRELAND) |
||
| Approx. Square Feet: | 183,000 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 certificates: ISO 13485:2003 - SCC  ,
ISO
13485:2003 - UKAS |
|
| 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. | ||
