To help Indian small and medium enterprises (SMEs) achieve access to global markets, UL, a worldwide leader in advancing safety, announced that Bangalore-based medical devices startup, Forus has been issued the prestigious ISO 13485 certification.
The standard ensures compliance of various aspects of a product lifecycle that affect safety and effectiveness of medical devices, including product design, prototype, manufacturing, installation, service and market surveillance of installed products. This enhances the credibility of Forus regulated markets, kicking off Forus' endeavor to penetrate markets outside India.
The medical device sector in India is witnessing a surge of start-ups keen on addressing the huge gap in healthcare access, and increasing their revenue potential from global markets. UL works with over 70 SMEs and start-ups in this sector.
"We are delighted about the ISO 13485 certification which confirms the compliance of standards and manufacturing process quality and innovation. Working with UL gave us a lot of insights into how regulatory compliance has to be a part of the product DNA itself, and not something that adds up at the end. The early-engagement program of UL greatly helped us understand what was involved in making our product ready, not just for India, but for various global markets as well', said Dr Shyam Vasudevarao, president & CTO Forus.
Forus is a pioneer of frugal innovation in ophthalmology, and its product, 3nethra is the world's first inexpensive, portable, ophthalmic pre-screening device. By identifying five major eye ailments, 3nethra negates the deployment of multiple, expensive devices.