During the market phase, when the medical device is being marketed and sold, the need for document control and collaboration software continues to be significant. Forms-based process automation solutions can also help by automating equipment maintenance/ calibration and tracking manufacturing processes. As during the commercialization phase, the automation of quality processes, such as training, change control, nonconformances, CAPAs, etc., is important during the market phase. The quality team continues to monitor manufacturing operations, and is also responsible during the market phase for resolving customer complaints. Using MasterControl analytics software, the quality team analyzes customer complaints, nonconformance issues, CAPAs, etc. for reporting purposes.
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MasterControl integrates the training process with the rest of the quality system for a holistic approach to quality management. If there's a change in a document linked to a required course because of a revised SOP, policy, etc., all affected trainees immediately receive new training tasks. MasterControl's reporting and analytic capabilities include customizable reports and online charting. The system automatically performs a gap analysis for all training tasks.
During the market phase, the regulatory team prepares the CE technical file(s) for the dossier, as well as other global submission documents necessary to secure foreign regulatory approval. In addition, the regulatory team may have letters to file for product derivatives. Members of the sales and marketing team also have many documents to manage during the market phase: publications in professional journals, sales and market data compilations, and competitive analyses and post-market clinical studies. A secure, centralized document repository can help both the regulatory team and the sales and marketing team by providing quick access to all product data and design documents.
To get comprehensive details about the market phase of medical device companies, feel free to contact MasterControl representative today.