Quality Assurance of Manufacturing Design

ISO 13485:2016 and ISO 9001:2015

Utitec, Inc
169 Callender Road
PO Box 370
Watertown, CT 06795
Phone: 860-945-0601
Email: sales@utitec.com

ISO 13485:2016 and ISO 9001:2015
FDA Registration Number: 3014032451

Utitec, Medical SA
Zona Franca Coyol
Building B-15
El Coyol de Alajuela
Costa Rica - Central America
P 506-2429-2000 F 506-2429-2016
Email: CR-CustomerService@utitec.com

Quality Assurance

All our equipment and processes are validated following FDA and ISO requirements.

Gage R&R studies are made when required in order to ensure the reliability of our measuring techniques and equipments.

A formal Risk Management process per ISO-14971 is in place to ensure that any potential hazard is identified and properly controlled.

Calibration

All our equipment is calibrated to traceable international standards.

Periodical measuring instrument verifications are performed by our personnel using certified standards.

Formal procedures for dealing with suspicious instruments and potentially affected products are in place.

Quality Control

Measuring:
Computer driven inspection systems.
Fully automatic based using validated routines.

State of the art special measuring equipments such as:
Digital profilometers.
Laser micrometers.
Digital passivation testers.

Rockwell, Vickers and Knoop hardness testing

Visual Inspection:
Optical magnification up to 360X.
Digital magnification up to 815X.

Documented visual inspection procedures to ensure objective criteria.

Control specimens for critical requirements.