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Technical Documentation for non-medical devices is basically the design history file and if applicable the essential requirement list of the specific directive. I would not use the Technical File structure of the MDR. That would be way to overkill. Make it simple. ------------------------------ Armin ...

Yes, Anne comment is very important that this is changing by establishing the QMSR. ------------------------------ Armin Beck CEO SunTrixConsulting LLC El Dorado Hills, CA 1-925-212-7683 armin.beck@suntrixmedical.com ------------------------------

There is only one way to claim that you have an equivalent device to a competitor device. You must have a written agreement with you competitor in place that state that you have full excess to all technical documentation including the clinical evaluation report. ------------------------------ Armin ...

I agree with Bianca. that kind of question is considered consulting and NBs are not allowed to provide consulting. Your clinical development plan should be very simple ------------------------------ Armin Beck CEO SunTrixConsulting LLC El Dorado Hills, CA 1-925-212-7683 armin.beck@suntrixmedical.com ...

Please contact me via email at armin.beck@suntrixmedical.com ------------------------------ Armin Beck CEO SunTrixConsulting LLC El Dorado Hills, CA 1-925-212-7683 armin.beck@suntrixmedical.com ------------------------------