About the product
Regulatory audit is a critical function for medical device organizations to manage; however the complexity of operations often hinders organizations from realizing the benefits of investing in research and new markets. A Regulatory Information Management System (RIMS) should be able to keep up with sprouting needs or else it can result in:
Longer cycle time for document compilation and application submission for approvals & filing updates, resulting in delays and revenue loss
Increased costs of compliance with impending regulations like EU MDR and IVDR
Lack of direct reporting capabilities result in blind spots for senior management within medical device organizations
Longer cycle time for document compilation and application submission for approvals & filing updates, resulting in delays and revenue loss
Increased costs of compliance with impending regulations like EU MDR and IVDR
Lack of direct reporting capabilities result in blind spots for senior management within medical device organizations
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