Health Products & Medical Devices
Health Products are defined as products used in medical, dental, and physiotherapy procedures, as well as in the diagnosis, treatment, rehabilitation, or monitoring of patients. They comprise biological products and medical devices.
Biological Products
Biological products are defined by the Food and Drug Administration (FDA) as products used to diagnose, prevent, treat, and cure diseases and medical conditions.
Biological products are a diverse category of products and are generally large, complex molecules.
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Medical Devices
According to World Health Organization (WHO), medical device is defined as an instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
The biocompatibility evaluation of your medical device is a mandatory part of the conformity assessment.
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