Advanced BioMedical Technologies Inc.'s Quality Management System
Receives ISO 13485:2003 Certification
NEW YORK and SHENZHEN, China, Jan. 15, 2013
/PRNewswire/ -- Advanced BioMedical Technologies Inc.
(OTCQB:ABMT), developer and manufacturer of orthopaedic internal
fixation devices, is delighted to announce that the Company's
Quality Management System (QMS) has been credited with ISO
13485:2003 certification.
The Company's Quality Management System (QMS) was certified by
the Chinese SFDA (Guangdong) to
meet YY/T 0287-2003 standard - the Chinese equivalent of ISO
13485:2003. According to the Chinese SFDA regulations, all mainland
Chinese medical device manufacturers must establish document,
implement and maintain a Quality Management System (QMS). Only the
manufacturers with a SFDA certified QMS are allowed to apply for
production permits and product registrations.
While the Company's facility and laboratory were under
renovation in 2012, the Company had been identifying the processes
needed for the Quality Management System and their application
throughout the organization. The Company has established its
quality objectives, the sequence and interaction of the quality
management processes and determined the criteria and methods needed
to ensure that both the operation and control of these processes
are effective. The QMS was considered to have met its objectives
and effectiveness after internal analysis and management reviews.
The Company submitted its certification request to the SFDA
(Guangdong). Having conducted
several on-site examinations in late 2012, the SFDA (Guangdong) accredited our QMS with YY/T
0287-2003/ISO 13485:2003.
Wang Hui, CEO of the Company,
said: "The SFDA certified QMS will enable the Company to
manufacture and market its products once they are approved by the
SFDA. Furthermore, Quality Management Systems around the world are
generally based on ISO 13485; this certification will help the
Company to be accredited in other countries in due course."
About Advanced Biomedical Technologies Inc. (OTCQB: ABMT)
Advanced Biomedical Technologies, Inc.'s primary product line
includes internal fixation devices (bone screws, pins, wires etc..)
consisting of proprietary high grade polymers (polyamide – "PA")
which allow the body to degrade the products during the healing
process. During the healing process, the products
stimulate new bone growth which replaces the degrading device,
leaving newer, stronger bone in the exact location of the injury;
thus making the site of the injury stronger and more resistant to
recurring damage. These products provide an alternative to
metal implants and overcome the limitations of other re-absorbable
fixation devices.
The products and materials that the Company has created differ
from competing bio-degradable and metal based products being
marketed today by:
- The ability to control the speed that the device
degrades; therefore improving upon the healing time.
- Eliminating the need for a second surgery to replace device
due to infection or other post-operative complications.
- The capability of being evenly absorbed from outer layer
inwards, so that it gives enough restoration time for bone healing
and re-growth.
About ISO 13285:2003
ISO 13485:2003 specifies requirements for a quality management
system where an organization needs to demonstrate its ability to
provide medical devices and related services that consistently meet
customer requirements and regulatory requirements applicable to
medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate
harmonized medical device regulatory requirements for quality
management systems. As a result, it includes some particular
requirements for medical devices and excludes some of the
requirements of ISO 9001 that are not appropriate as regulatory
requirements. Because of these exclusions, organizations whose
quality management systems conform to this International Standard
cannot claim conformity to ISO 9001 unless their quality management
systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations
providing medical devices, regardless of the type or size of the
organization.
If regulatory requirements permit exclusions of design and
development controls, this can be used as a justification for their
exclusion from the quality management system. These regulations can
provide alternative arrangements that are to be addressed in the
quality management system. It is the responsibility of the
organization to ensure that claims of conformity with ISO
13485:2003 reflect exclusion of design and development
controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not
applicable due to the nature of the medical device(s) for which the
quality management system is applied, the organization does not
need to include such a requirement(s) in its quality management
system.
The processes required by ISO 13485:2003, which are applicable
to the medical device(s), but which are not performed by the
organization, are the responsibility of the organization and are
accounted for in the organization's quality management system.
Forward-Looking Statements
This release contains forward-looking statements which are made
pursuant to provisions of Section 21E of the Securities Exchange
Act of 1934. Investors are cautioned that such statements in this
release, including statements relating to regulatory and business
strategies, plans and objectives of management and growth
opportunities for existing or proposed products, constitute
forward-looking statements which involve risks and uncertainties
that could cause actual results to differ materially from those
anticipated by the forward-looking statements. The risks and
uncertainties include, without limitation, risks that product
candidates may fail in the clinic or may not be successfully
marketed or manufactured, we may lack financial resources to
complete development or marketing of our products, government
regulatory agencies may interpret the results of studies
differently than us, competing products may be more successful,
demand for new pharmaceutical products may decrease, the
biopharmaceutical industry may experience negative market trends,
our continuing efforts to develop bone fixation devices may be
unsuccessful, our common stock could be delisted from the
over-the-counter market, and other risks and challenges detailed in
our filings with the U.S. Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on any
forward-looking statements which speak only as of the date of this
release. We undertake no obligation to publicly release the results
of any revisions to these forward-looking statements that may be
made to reflect events or circumstances that occur after the date
of this release or to reflect the occurrence of unanticipated
events.
Contact:
Chiming Yu
TEL: 718-766-7898
Kai Gui
TEL: 718-766-7898
EMAIL: info@abtbiomedical.com
SOURCE Advanced BioMedical Technologies Inc.
