Over 350 medical companies rely on MasterControl for connecting quality document and data processes that drive efficiency and actionable insights to help you accelerate breakthrough medical innovations. The MasterControl product lifecycle excellence platform is designed to provide medical device companies a single source of truth for product quality data across the entire enterprise and the wider ecosystem. It helps ensure that all teams working in regulatory, quality, supplier, manufacturing and postmarket functions can access the information they need to do their jobs more efficiently and effectively.
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During the medical device development process, companies will stumble upon problems such as regulatory issues, limited resources, and timely delivery of finished products. Regulatory requirements such as 21 CFR Part 820, otherwise known as the Quality System Regulation (QSR), and ISO 13485, outline elements which, while intended to ensure product quality and safety, may often be viewed as contributing factors to such stumbling blocks. The MasterControl Product Lifecycle Excellence solutions help medical device companies leverage compliance requirements as an advantage by automating and accelerating quality and compliance processes throughout the entire product lifecycle - from product concept to commercialization - all on the MasterControl Platform™.
Global regulatory oversight of the medical device industry is at an all-time high; particularly in the areas of design, data and supplier control. Consumers, as well as industry stakeholders, are demanding better, safer products, and regulators are being compelled to act on their demands. To stay on top of these intense business and regulatory demands, medical device companies of all sizes throughout the world are turning to MasterControl to automate and streamline processes and enhance product development lifecycles to improve efficiencies and ensure compliance.
MasterControl allows users to access information and perform tasks using a tablet or a smartphone. Mobile access offers greater flexibility for users and helps boost overall efficiency and productivity.
Cloud technologies are a necessity for medical device companies. Those without access to its speed and adaptability will struggle to maintain a competitive edge. MasterControl isn't just a cloud-based solution. It's dedicated teams and specialized tools ready to make your implementation simple and your experience seamless.
MasterControl provides an effective framework for a company's quality management system (QMS) by automating all documents- and forms-based processes, connecting all quality processes, and providing a web-based, centralized location for all documents and data.