Advanced Oncotherapy PLC ISO 13485:2016 certification for medical devices (5670N)
21 January 2019 - 6:00PM
UK Regulatory
TIDMAVO
RNS Number : 5670N
Advanced Oncotherapy PLC
21 January 2019
ADVANCED ONCOTHERAPY PLC
("Advanced Oncotherapy" or the "Company")
ISO 13485:2016 certification for medical devices
Advanced Oncotherapy (AIM: AVO), the developer of a
next-generation proton therapy system for cancer treatment,
together with its subsidiary ADAM S.A., announces that it has
obtained ISO 13485:2016 certification. The certification was
awarded following an audit by independent compliance specialists
Lloyd's Register.
ISO 13485:2016 is the internationally recognised quality
standard to ensure the consistent design, development, production,
installation and sale of medical devices that are safe for their
intended purposes.
This certification represents an important milestone for the
Company. It reflects its commitment to safety and to providing a
high-quality product and shows the focus that the Company has on
risk-based decision making throughout the organisation.
This certification enables Advanced Oncotherapy and ADAM S.A. to
continue to develop the LIGHT proton therapy system in compliance
with the highest standards for safety and product performance, and
to make its product available for the first patient treatment, once
the LIGHT proton therapy system medical device file has been
approved.
Dr Michel Baelen, Advanced Oncotherapy's Director of Regulatory
Affairs and former Vice President for IBA's Regulatory and Quality
Assurance Affairs, said: "This successful audit demonstrates our
dedication to ensuring that the infrastructure to develop and
manufacture our product is safe, effective and reliable. Advanced
Oncotherapy's and ADAM S.A.'s compliance with this standard
illustrates the importance that it places on the quality of its
product and the need to have robust processes across our entire
organisation in accordance with the stringent requirements
associated with medical devices."
For further information, please contact:
Advanced Oncotherapy Plc www.avoplc.com
Dr. Michael Sinclair, Executive Tel: +44 20 3617 8728
Chairman
Nicolas Serandour, CEO
Stockdale Securities (Nomad &
Joint Broker)
Antonio Bossi Tel: +44 20 7601 6100
Stifel Nicolaus Europe (Joint
Broker)
Jonathan Senior Tel: +44 20 7710 7600
Walbrook PR (Financial PR & IR) Tel: +44 20 7933 8780 or avo@walbrookpr.com
Paul McManus / Anna Dunphy Mob: +44 7980 541 893 / Mob: +44
7876 741 001
About Advanced Oncotherapy Plc www.avoplc.com
Advanced Oncotherapy is a provider of particle therapy in the
treatment of cancer, which harnesses the very best in modern
technology. Advanced Oncotherapy's R&D team, ADAM, in Geneva,
focuses on the development of a proprietary proton accelerator -
LIGHT (Linac Image Guided Hadron Technology). LIGHT accelerates
protons to the energy levels achieved in legacy machines but in a
compact and truly modular unit, offering significant cost
advantages. LIGHT also delivers proton beams in a way that
facilitates greater precision and electronic control, which are not
achievable with currently available alternative technologies.
Advanced Oncotherapy will offer healthcare providers affordable
systems that will enable them to treat cancer with an innovative
technology, offering better health outcomes and lower treatment
related side effects.
Advanced Oncotherapy continually monitors the market for any
emerging improvements in delivering proton or particle therapy and
actively seeks working relationships with providers of these
innovative technologies. Through these relationships, the Company
will remain the prime provider of cutting edge, cost-effective
systems for particle therapy.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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