ISO 13485 is a quality standard for organisations that design, develop, produce or service medical devices. It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485 certification services in Raigarh, Raipur, Ambikapur, Delhi. Bhiwani, Ambala, Aligarh, Meerut.