ISO 13485 in Malaysia is applicable to any type of medical device manufacturer, and ISO 13485 certification is granted to an organization that can demonstrate that it has an effective quality management system for medical devices.Certification of ISO 13485 in Malaysia is not limited to product manufacturers, but also includes service providers, distributors, and laboratories that are involved in the life-cycle of a medical device/equipment. https://ias-malaysia.com/iso-1....3485-certification-i