If you are in the medical device industry, specifically in the Indian market, you have likely come across references to a "23485" file. Often circulated as , this archive typically contains the IS 23485:2019 standard—the foundational document for quality management systems (QMS) in India. What is IS 23485?
The file is likely a digital copy of the IS 23485:2019 standard, which outlines the quality management system (QMS) requirements for medical device manufacturers in India.
: Steps to map device lifecycles and conduct gap analyses against current practices.
: Detailing the legal and technical requirements for safety and performance.