Medical device regulators in most markets require device companies to maintain a quality management system to obtain device approvals and registrations. Some markets recognize certification to international standards like ISO 13485; other markets require compliance with a local quality management regulation. Failure to comply with quality system requirements can prevent approvals and registration as well as jeopardize your standing with regulators post-market and disrupt product sales.
Emergo’s quality management consultants bring decades of experience with medical device QMS development, implementation, and audits for all device risk levels. We can help you establish and maintain a quality management system that meets QMS requirements wherever your product is sold.
Achieve QMS compliance in medical device markets worldwide
We develop, implement, and maintain integrated quality management systems that comply with QMS regulations in all major medical device markets, including:
We also assist with gap analyses, due diligence, and internal, supplier, and preassessment audits. Our consultants guide you through every step of the process, including writing quality management system procedures, conducting and monitoring the implementation, and training your employees. We also assist in on-going compliance and maintenance of your QMS following implementation and certification (where applicable). Explore all our QMS compliance services.
Risk and quality management in one integrated system
As the regulatory landscape evolves toward a lifecycle approach that emphasizes risk management, medical device companies must incorporate risk management processes throughout their business. Integrating risk management into your quality management systems is the optimal approach. If you already have an ISO 13485 or FDA QSR quality system, we can design and document a system for managing and evaluating risk that meets the requirements for ISO 14971. Learn more about risk management consulting.