Acrobot awarded international quality certifications

ISO and MDD approvals secured for company-wide quality management system and novel computer assisted surgical technology products

London, April 2008 … The Acrobot Company Limited (Acrobot), computer-assisted surgery specialists, has secured MDD 93/42/EEC approvals for its innovative Acrobot® Planner and Acrobot® Navigation products and ISO 9001:2000 and 13485:2003 awards for its company-wide quality management system (QMS).

Acrobot’s QMS was assessed by an independent notified body which will also regularly review the Company’s ongoing efficacy. The ISO 9001 international standard recognises Acrobot’s full compliance with regulations determining design, development, production, installation and servicing. ISO 13485, an accolade specifc to medical devices, is awarded in recognition of compliance with additional standards for design controls, traceability, record retention and regulatory actions: all critical to the sector.

The award of full compliance with the Medical Devices Directive, MDD 93/42 EEC, confirms that Acrobot meets all mandatory European standards covering all aspects of product manufacturing, safety and performance. Additionally, Acrobot’s QMS was found to meet all relevant requirements of the U.S. Code of Federal Regulations Title 21 CFR Part 820, which defines standards for medical devices.

Graeme Brookes, CEO of Acrobot, commented: “We are pleased to secure these prestigious, high profile and industry specific approvals, which represent a major milestone for the development of our business. Acrobot is committed to providing a total quality service to its customers, both surgeons and patients, ensuring that they receive consistently high quality products that comply with internationally recognised quality standards.”

Paula Gomes, Operations Director of Acrobot, said: “Quality is an integral part of every aspect of our business. We are delighted that the systematic and independent examination of our quality management system, carried out by a third party on behalf of the Medical and Healthcare Regulatory Agency (MHRA), was successful and demonstrated our full compliance with ISO standards. In addition, complying with US regulations represents a significant step towards securing approvals and launching our products in the North American market.”

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For further information, or to arrange an interview, please contact: Tony Stephenson or Tristan Jervis, +44 (0) 20 7457 2020 or email tony.stephenson@collegehill.com

- Notes to editors -

Acrobot® provides precision surgical systems for computer-assisted 3D planning, surgical navigation and surgeon-controlled robotic surgery. The overall goal of Acrobot’s technologies is to provide speed, accuracy and reproducibility, enhancing clinical outcomes, whilst augmenting surgeon skills and facilitating bone conservation and increasing productivity. Acrobot’s currently available portfolio includes Acrobot Planner, which offers 3D surgical planning and visualization software and Acrobot Navigation, which uses a unique mechanical method to track conventional surgical instruments relative to the patient to achieve high surgical accuracy. Acrobot is also progressing the development of the Acrobot Sculptor® Robotic System, a motorised programmable device, which uses patent protected ‘active constraint’ technology to prevent a surgeon accidentally moving outside a specified area. This cutting edge robotic solution is at an advanced development stage, undergoing final clinical evaluation prior to commercial release in 2008.
 
www.acrobot.co.uk