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View Full Version : Re: Surgical Planning Software



Hamid Rassoulian
09-13-2001, 02:04 AM
Dear Colleagues,


It is highly admirable that the fruits of labour are made available for use by both the research as well as the health care community. On the other hand, it is important to appreciate that such generous act must still be carried out with full consideration of various legal issues surrounding and regulating the use of devices and systems for health care, namely the Medical Devices Directive, and the associated statutory instruments of individual member nations of the EU.

A good question to ask would be, if the software on offer, had been CE marked, and if not, how can it be made available in view of clear guidelines to the contrary.

I hope this is not interpreted as being legally pedantic, but a realistic view of current implementation of the harmonized standards across EU.

With kindest regards


Hamid




Dr. Hamid Rassoulian MIPEM, SRCS
Head of Clinical Bioengineering
Southampton University Hospitals NHS Trust
Southampton General Hospital
SO16 6YD
United Kingdom



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