A Case Study on Skanray Technologies, Mysore India this Study for The medical device industry in India is expected to grow in the double digits to $11bn by 2023, it is still fairly new and in many cases, lacks formal regulatory oversight. The majority of device manufacturing is limited to low-value produced such as catheters, IV sets, needles, medical electronics, orthopaedic implants, condoms and syringes. Many device manufacturers in India are small to medium enterprises and due to the lack of a strict regulation, high price sensitivity, and unique needs of the population, many of the devices manufactured in India are sold and used in India.
Challenge: Manufacturers of medical devices fall under the regulatory oversight of the countries where they are purchased and used. In most cases, not only do regulators require test and clinical data that shows a device is safe and effective for its intended use, but they also require assurance that the quality of the device and all the components that go into it will not be compromised during the manufacturing process.“We have been looking at the global market since inception, so the first thing that we established in Skanray was a very robust quality system and compliance to international regulatory requirements” said Mr. Vishwaprasad Alva, Managing Director & CEO, SkanRay Technologies Pvt. Ltd..
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