| Qualitel
is uniquely qualified to serve the medical
industry. With requirements of high-mix,
high-complexity, and high-reliability requirements
with low volume, Qualitel is focused to meet this.
Our philosophy of "doing it right the first
time" through early planning at the quoting
stage is an attribute that guarantees on-time
delivery and high quality. Qualitel provides
extensive engineering, manufacturing, and
logistical services for the medical industry and
has an experienced staff of personnel that are
well versed in the regulatory and compliance
issues associated with the manufacture and test of
these products.
Products
Manufactured:
Ultrasound
Equipment
Medical
Devices
Manufacturing
Capabilities:
Qualitel
is an FDA class I/II registered facility. Qualitel
manufactures medical products to IPC Class II/III
or as required by our customer. In addition,
we have operators that are certified with
J-STD-001 Workmanship. Internal processes conform
to FDA guidelines ensuring traceability of
materials and fabricated product. Qualitel
utilizes the expertise of its manufacturing and
test engineers along with the skilled
manufacturing personnel in the production and test
of medical equipment. Rigorous quality programs
are in place to ensure compliance with all
customer requirements and Qualitel is registered to
ISO13485
Medical Devices on August 5, 2005. |
