I3CGLOBAL Blogs

If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how…

Manufacturers of medical devices that wish to enter the U.S. market must follow the FDA’s 510k procedure. “How long does it take to get…

Two worldwide standards that stand out in the context of quality management are ISO 9001 and ISO 13485.

As it is today, America remains the largest importer of food products; thus, entities involved in the production and supplying of food…

High-quality medical equipment is a key determinant in the delivery of quality health care services in the healthcare industry.

It’s not always obvious if a given product needs FDA 510k Clearance and approval, even though the US medical device market entry process…

As a means of entering the U.S. market, companies producing medical devices, medications, and related products must follow steps set by the…

One of the vital aspects in drug development is the clinical assessment of products to be marketed. It helps ascertain that a drug is free…

With the current wave of globalization, the environment for any firm wishing to establish itself within the European Union (EU) has a…