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Acrobot is committed to
providing a total quality service to its customers. Quality is an
integral part of every aspect of our business. Acrobot operates within
a Quality Management System which embraces all key business processes.
This ensures that our customers (surgeons and patients) receive
consistently high quality products in compliance with internationally
recognised quality standards.
Acrobot consistently provides a high level of quality assurance to
satisfy stringent regulatory requirements. To guarantee this
quality, we are continually assessed by a Notified Body to review the
ongoing efficacy of our quality management system.

The award of this International Standard demonstrates compliance of our
Quality Management System to the requirements of ISO 9001:2000 in all
the key areas, such as Design, Development, Production, Installation
and Servicing.

ISO 13485 is specific to medical devices quality systems and
supplements the ISO 9001 standard. Some of the additional requirements
relate to design controls, traceability, record retention and
regulatory actions, which are critical for the medical devices industry.
The award of this International Standard demonstrates compliance of our
Medical Devices - Quality Management Systems to the regulatory
requirements.

The Medical Devices Directive, mandatory for all medical devices since
June 1998, is the European standard to which all medical devices must
comply. The Directive covers all aspects of product manufacturing,
safety and performance.
For more information write to us
at:
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