Regulatory documentation for Medical devices/In vitro diagnostics:

YES Pharma Consultancy B.V. has compiled various parts of technical files for medical devices and in vitro diagnostics. For example risk analysis, technical documents, and design dossiers have been written meeting the requirements of Dir. 93/42/EC and Dir. 98/79/EC and the belonging guidance documents. Moreover, we have prepared toxicological and (non) clinical overviews and summaries according to the clinical guidance documents. We assist you in choosing your notified body and we also assist during the certification procedure.

Product development:

YES provides advice in product development. We assess product suitability for the Dutch market according the medical device directives, followed by advice on the classification of the medical device and possible certification and notification procedures. We cooperate with formulation technologists, manufacturers, analytic laboratories, and distributors.