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How To Take Your Medical Device From Idea To Regulatory Approved Product

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This video is based on a conference talk that happened on the 12th of January at India Electronics Week 2016.

Presented by: Nitesh Kumar Jangir, Co-Founder, Coeo Labs Pvt Ltd

As per the report published by Federation of Indian Chambers of Commerce and Industry (FICCI) says that the Indian Medical Devices industry is valued at US$ 2.5 billion. Moreover, it is growing at a faster annual rate of 15%. A rise in the number of hospitals and the increased requirement for healthcare facilities creates a need for sophisticated devices and equipment, which can provide accurate treatment to individuals. The medical electronics segment of this industry incorporates control, conversion, sensing, processing, storage, display, and transfer of information on anatomy and physiology by making use of the Electronics and Communication Technologies.

Developing an innovative medical product which can get regulatory approval is time and resource intensive. Designers can optimise the time and resource in product development by taking care of the standards( ex.IEC 60601-1) and implementing design rules for medical electronics. The talk will take you through processes and techniques for the design of medical devices.

WHAT YOU GAIN: Learn about medical device regulations, standards and techniques to comply with regulatory standards. Gain knowledge about common risks and mitigation techniques in medical device development.


• Need for medical device innovation and design in India

• Challenges in designing a medical device. (Clinical, regulatory and resource)

• Mitigation techniques and processes.

• Opportunities for electronics designers.

06_How to take your medical device from idea to regulatory approved product from EFY on Vimeo.

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