Avita Medical Completes ISO Quality Audit, CE Mark Recertification
NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM -- (Marketwire) --
02/13/13 -- Avita Medical Ltd. (ASX: AVH) (OTCQX: AVMXY)
-- SUCCESSFUL COMPLETION OF ISO QUALITY RECERTIFICATION AUDIT
-- RECEIVES ISO 9000, ISO 13485 AND MED DEVICE DIRECTIVE RECERTIFICATION
-- FREE TO CE MARK ALL REGENERATIVE AND RESPIRATORY PRODUCTS FOR SALE IN
THE EUROPEAN UNION
Regenerative medicine company Avita Medical Ltd. (ASX: AVH) (OTCQX:
AVMXY) today announced that it has received formal notification of
successful completion of the annual ISO Quality Recertification Audit
conducted 8-9 January 2013. The Quality Audit, conducted by an
independent, external auditor of the European Notified Body, covered
all applicable elements of ISO 9001:2008 Quality Management System
Certification, ISO 13485:2003 Medical Devices Certification, Medical
Devices Directive 93/42/EEC and Canadian Medical Devices Regulation
Part for Avita's Class III Medical Devices. No Major or Minor
Non-Conformances were identified in the audit.
The ISO Quality Audit is a rigorous and comprehensive recertification
audit to all of the required elements of the directives; successful
ISO recertification is a requirement in order for Avita Medical to
maintain its CE mark on its regenerative and respiratory products for
sale within the European Union and Canada as well as a reference for
registration in other countries, including the Middle East and
The audit addressed all phases of Avita Medical's Quality,
Manufacturing and Management Systems as well as a comprehensive
review and verification of controls on its portfolio of medical
products including the Regenerative product, ReCell(R) Spray-On
Skin(R), and the company's respiratory products (Funhaler(R) and
Mr. William Marshall, Avita Medical's VP Operations and Regulatory,
said: "Avita maintains a strong commitment to the quality of our
products and to our customers. We continue to improve and streamline
the company's Quality System and we are very pleased with the result
of the audit."
"Tight control of Quality and Manufacturing Systems are a
prerequisite for efficient operations," said Mr. Timothy Rooney,
Chief Financial Officer and Chief Operating Officer. "The company has
in place a formal Continuous Improvement system which has yielded
significantly improved margins and reductions in operating costs.
This is part of an on-going effort to deliver the highest quality
products to our customers while maximizing efficiency of
manufacturing and operations."
ABOUT AVITA MEDICAL LTD.
Avita Medical (http://www.avitamedical.com/) develops and distributes
regenerative products for the treatment of a broad range of wounds,
scars and skin defects. Avita's patented and proprietary
tissue-culture, collection and application technology provides
innovative treatment solutions derived from a patient's own skin. The
company's lead product, ReCell(R) Spray-On Skin(TM), is used in a
wide variety of burns, chronic wounds, plastic, reconstructive and
cosmetic procedures. ReCell is patented, CE-marked for Europe,
TGA-registered in Australia, and SFDA-cleared in China. ReCell is not
available for sale in the United States; in the US ReCell is an
investigational device limited by federal law to investigational use.
An FDA trial on the safety and efficacy of ReCell is in process.
Avita Medical Ltd.
Stella Sung, Ph.D.
Business Development Officer
ProActive Capital Resources Group, LLC
641 Lexington Avenue, 6th Floor
New York, NY. 10022
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