Product Information

MasterControl Registrations™

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Data Sheet 1 Data Sheet REGULATORY MANAGER DOCUMENTS TASKS MILESTONES MONITORING CHECKLISTS AUDITS JAPAN UNITED STATES AUSTRALIA OTHER COUNTRIES EUROPEAN UNION MasterControl Registrations™ Registering new products in different countries is a time-consuming and nerve- wracking process. For medical device firms, the process is part of an intense period of obtaining a 510(k) clearance or a premarket approval (PMA) in the United States. While the information required is essentially the same for various registrations, the preparation, presentation, and the depth of information submitted vary greatly depending on the country. Re-registration of a medical device is no less demanding because requirements may change over time. What is MasterControl Registrations? MasterControl Registrations is a holistic solution for product registration and submission management that will automate your manual or hybrid processes. It will streamline control of documents and timelines, as well as tracking of various requirements for every geographic location. It will create transparency for effective monitoring of bottlenecks within your organization and those involving regulators.

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