Key points when engaging in activities which relating to medical device
It is important to understand that a product is considered as a medical device if : Firstly : A product line may be classified as a medical device if it is an instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets simultaneously the requirements including: (i) It is intended, by the product owner, to be used, whether alone or in combination, for human beings for one or more the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception, disinfection of medical devices; providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body. And (ii) T...