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.
