ISO 13485 is an effective solution to meet the comprehensive requirements for a quality management system. It provides the basis for ensuring the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. Adopting this standard is beneficial to the organization in many ways: It demonstrates the manufacturer's ability to supply medical devices & related services that are compliant with all regulatory requirements.it also assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.