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As per MDR, ‘ medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimen derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
BioReg experts specialize in regulatory strategy for medical devices and support all development, registration, and post-market activities in the various markets worldwide.
Our focus is EU-MDR, FDA (510K), Health Canada and Israel.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.