| |
March 22, 2004
NeoSurg
Technologies, Inc. Receives ISO 13485 Certification
ISO 13485 Is A Major Milestone In Worldwide Commercialization Strategy
Houston, TX March 22,
2004 - NeoSurg Technologies, Inc., a leading developer of minimally
invasive access products for laparoscopic surgery, today announced that it has
received ISO 13485 Quality Certification from KEMA Medical based in the
Netherlands, a quality management systems registrar.
The ISO 13485:2003 standards, released in July 2003 as the successor to ISO
13485:1996, is an internationally recognized quality management system standard
developed by the International Organization for Standardization (ISO). To be
certified to the standard, companies must implement a quality management system
(QMS) embracing the activities of the company from staff training to taking the
instruction from the customer, the design and development of products, the
purchasing of materials and services and the delivery of the products and
services, with all aspects of medical device, regulatory and industry
requirements being addressed.
"NeoSurg Technologies, Inc. has always been committed to providing the highest
levels of service excellence" stated Pete O’Heeron, NeoSurg’s CEO. "We are
proud to be certified to ISO 13485. This demonstrates that our focus remains on
quality, world-class performance, and continuously monitoring our business
operations to ensure that we deliver on the promises we make to our customers,
employees and vendors. By earning ISO 13485 certification, NeoSurg is
demonstrating its commitment to quality.
"The NeoSurg team enthusiastically embraced and assisted in the development of
the QMS. The management implementation team oversaw each stage of development
and insured scheduled progress was timely, efficient and effective. We are very
proud to have gained certification," stated Lisa Martinez, NeoSurg’s Quality
Manager.
About the T2000 System
The T2000 System consists of a Reusable Trocar constructed of titanium and hard
anodized aluminum for durability and reliability. The access tip is disposable
which provides the surgeon with a consistently sharp and controlled penetration. A
locking shielding mechanism is attached to the main trocar to guard the tip
during insertion.
About NeoSurg Technologies
NeoSurg Technologies, Inc., based in Houston, Texas, is a privately held medical
device company focused on bringing breakthrough products for minimally invasive
surgery to market. These products are based on the Company’s patented
technology, which allows the combination of disposable components with reusable
components in a sophisticated and reliable system.
For more information on NeoSurg Technologies, Inc. visit the company Website at
www.neosurg.com or contact:
Pete O’Heeron
President and Chief Executive Officer
(281) 461-6211
poheeron@neosurg.com
Certain statements made by the Company which are not historical facts may be
considered forward-looking statements, including, and without limitation,
statements as to trends, management’s beliefs, expectations and opinions, which
are based upon a number of assumptions concerning future conditions that
ultimately may prove to be inaccurate. Such forward-looking statements are
subject to risks and uncertainties and may be affected by various factors, which
may cause actual results to differ materially from those forward-looking
statements.
.
|
|