ISO 13485 certification consultant in India. The ISO 13485 is one such standard that must be complied by the manufacturers of medical products and devices to ensure the best level of safety and health of the customers. It is a set of instructions that must be followed by the manufacturers so that there is maintenance of best level of quality along with continual improvement. The ISO 13485 certification is meant to provide enough information about the major requirements for an efficient and effective quality management system that can be utilized for designing, development, manufacturing and marketing of the medical products.