Smart QMed

WE CONFORM YOUR MEDICAL DEVICE QUALITY AND REGULATORY REQUIREMENTS EFFECTIVE, SUCCESSFUL & EFFICIENT (PAPER-WISE AND ELECTRONIC-WISE) Lack of Quality Management System in a medical device company could cost a lot specially when it leads to conduct rework, recall or even handling complaints or when enforces companies to Regulatory Authority challenges such as US FDA warning letter. Specifically, where FDA clearly states that: "Quality should be built into the product and testing alone cannot be relied to ensure product quality." This is the reason that every medical device company has a Quality Management System; however, it does not mean every medical device company has a good Quality Management System. A company might be able to meet regulatory requirements for Quality Management System, but that doesn't indicate that the system is robust. Without a solid quality substructure, organizations are simply not ready to face the challenges of the regulatory environment and it could lead to miss the competitive market. An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, and ultimately, for ensuring market success. In addition, an optimal system will afford organizations the unnecessary, and often incredible, costs of poor quality. Smart QMed is here to assist companies with Quality and Regulatory compliance requirements by offering expert consulting and providing neat and organized documentation to obtain Medical Device submission and approval, specifically for US FDA, Health Canada and EU according to the latest and newest regulations. In addition, the key element of Smart QMed is superpowers IT team which modernize and computerize QMS document electronically. It includes not only the Quality Management System documentation, but also all document in a Medical device life cycle from design and development to production. Smart QMed offers the following QMS features for optimizing your documentation

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