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Acrobot is proud to be quality approved to ISO 9001:2008, ISO 13485:2003 and MDD 93/42/EEC

 

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 9001:2008 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.

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Acrobot - making life better for the patient and easier for the surgeon