- 1- Вы задавались вопросами:
- 21. «Можно ли, внести изменения в РУ 2006 г.?»
- 22. «Требуется ли, переоформление РУ при смене организационной формы?»
- 23. «Как присвоить вид медицинского изделия в соответствии с Приказом № 4н от 06.06.2012 г.?
We appreciate cooperation with your company as we've been working together for several years.
With your help, numerous medical products manufactured by us and mainly of hight risk classes (2b and 3 risk classes) were registered. Obtainment of MA is the result of hard and thorough work from design of the product to start of its production and completion of the registration procedure.
The list of works performed by your company for our enterprise includes: Making amendments to the registration dossier due to changes of regulations of the registering authority, preparation of expertise assessment for carrying out of clinical trials without participation of patients.
By virtue of your openness, creativity, clear arrangement of actions, we timely passed the registration process without problems and obtained 4 MA's for the following medical products:
- LC.08.ice system of electric stimulation of the phrenic nerve
- LC.09.ice system of electric stimulation of peripheric nerve
- LC.10.ice system of electric stimulation of the central nervous system
- NeyC-3M apparatus for electric stimulation with appliances
We express our sincere gratitude for the performed works. Especially, we would like to mention your professionalism and careful attitude towards your clients.
We wish you welfare, professional development and successful achievement of your goals!
General Director - I. A. Belov