This is an industry specific management standard specially developed for medical devices manufacturing industry. The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is suitable for all the organizations involved in the medical device lifecycle and looking for an improvement in the way it is operated and managed. regardless of the type or size of the organization.

Key benefits of ISO 13485
•    Meet regulatory requirements
•    Demonstrate that medical devices are produced safely
•    Increase device sales by accessing more markets