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. |
