Iso 13485 Certification

CDG Inspection Ltd.ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
Design and develop medical devices to international quality standards, ensure smooth submission, meet ISO 13485 standards, satisfy customers and keep ahead of all regulatory developments with our medical devices training courses.
ISO 13485 is an ISO Standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It's the quality management standard specifically designed for organizations that provide medical devices or related services to ensure that customer and regulatory requirements are consistently met
ISO 13485 is the quality standard designed for medical device manufacturers. ISO 13485 is also an international standard that is commonly used as the basis of regulatory compliance for the FDA. If you are a medical device manufacturer, BioMed/Pharma, or perform work with medical device manufacturing or distribution, ISO 13485 is an essential quality standard for your organization.