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Prosurgics strives continuously to improve the quality of products and processes throughout our organisation. Our commitment to quality is reflected by our accreditation to ISO13485: 2003 and ISO9001:2000; BS EN ISO 9001:2000; ANSI/ASQ9001:2000 the recognised leading international standards for quality and business management in the medical devices industry. Indeed, we were proud to be among the first companies to be awarded the latest version of the ISO standard, a demonstration of our commitment to a policy of continuous improvement.

Our Quality Management System is regularly audited by Underwriters Laboratories Inc, a leading international quality assessment organisation, in addition to our regular programme of internal audits

Our quality system is not only concerned with product quality, safety and reliability, it is also concerned with ensuring that in all interactions we will meet or exceed our customers’ expectations. Our commitment to our customers starts on our first meeting and continues long after a purchase. We pride ourselves on providing excellent training and support from our offices in the UK and USA, and via our local partners throughout the world.

All Prosurgics products are independently tested for compliance with safety and regulatory requirements for surgical equipment, in particular, the International Standard for Electromedical Equipment IEC 60601-1. Software incorporated in our products is developed according to the requirements of the International Standard for Medical Software ANSI/AAMI SW68. In addition, Prosurgics’ products are approved for sale under national regulatory requirements in each country where they are sold. Within the EU, our products carry the CE mark, which indicates compliance with the Medical Devices Directive 93/42/EEC. Prosurgics products marketed within the USA have been cleared by the FDA.

Prosurgics has taken the lead in a number of international initiatives to promote quality and safety of high technology medical equipment. The quality of design and manufacture of Prosurgics’ products consistently exceeds the standards required by regulatory authorities and we are committed to our goal of improving clinical outcomes and efficiency.

 

 

 

 


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