ISO Certification for Medical Device Companies

ISO Certification for Medical Device Companies

A company is ISO compliant when it demonstrates that it follows International Organization for Standardization guidelines. Global commercialization of your medical device most often requires ISO 13485 Certification.

ISO 13485 is a quality management system standard designed for medical device companies. ISO 13485 compliance shows a commitment to the safety and quality of your medical devices. Our team will help you:
• Establish a risk based approach to product development and realization
• Complete the validation of processes
• Ensure compliance with regulatory requirements
• Implement effective product traceability and recall systems

ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, associated with their products and to create the necessary controls to monitor them. Our medical device consultants work with you to:
• Assess the essential performance of your medical device
• Identify potential hazards
• Estimate the severity and likelihood of the hazards
• Create controls to minimize the risks

ISO 9001 specifies the requirements for a quality management system for companies that need to demonstrate their ability to provide a product that meets both customer and regulatory requirements. Our quality professionals help medical device companies become ISO 9001 compliant by helping:
• Implement a Quality Management System
• Create standard operating procedures
• Conduct QMS audits
• Deliver consistent services based on a QMS