Tektran has made a checklist of these items an integral part of its design process. When our team engages a design, it does so with this aforementioned learning curve already in place. Our knowledge base is put to work immediately to assist our clients in defining issues related to safety and to effectively interfacing their proprietary device to the power source required. There are appropriate uses of monopolar, bipolar, isolated, and ground referenced outputs. Frequency, power levels, load impedances, the environment, methods of current delivery, current modes, and modulation techniques may have different clinical effects on tissue.
Emails are great for progress reports and exchange of information.
A number of team members can be copied with one transmission, so all those involved in the effort are kept informed. You should insist on regular progress reports. As long as obligations are met to the end of each phase, a client can pull out any time. Risk Assessment and Analysis should be carefully documented. These visits are based on a documented Inspectional Strategy posted on the FDA website.