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Medical Technology Products. Medical and Regulatory Standards

Medical technology is an expansive term that implies diverse products, services, or solutions that are intended to improve health and well-being. Medical technology can include medical devices, in vitro diagnostics, digital health tools, and other products that are intended for medical purposes. Medical technology can help prevent, diagnose, monitor, treat, and care for human beings in different settings and stages of life.

Some of the products are regulated, while others may not yet be regulated. Medical devices have come to be increasingly regulated. Many in vitro diagnostics are also regulated. It is important for developers of medical technology products to know the regulatory standards that apply to the product.

A medical device, In vitro diagnostics, or medical technology developer could focus on his core expertise and resources in the technology and collaborate with an expert for guidance on regulatory pathways and medical positioning of the product.