Page 35 - Safety Risk Management for Medical Devices
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14    Safety Risk Management for Medical Devices


                   b. Distributed Systems
                      These are Systems that are comprised of multiple components from the
                      perspective of the user, and require integration by the user. Example: a spinal
                      cord stimulation System shown below with 6 individually integral components.
                      Each integral component is separately packaged and delivered to the user. Final
                      assembly and integration into a working System is done by the user.
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