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Getting new medical devices to market requires regulatory affairs teams to properly decipher entrance requirements and coordinate the assembly of complex submission dossiers for each country. Manually managing these processes over email and spreadsheets only increases the challenge.
Rimsys simplifies global submission management with access to quality regulatory intelligence, and integrated tools that provide complete control over submission authoring, assembly, and publishing.
Access information and government-specific templates for over 80 different countries
Build submission plans using fully customizable templates for FDA 510(k), STED, and other common market applications
Create, edit, and share structured submission content without external documents or spreadsheets
Assign tasks, track communications with health authorities, and manage approval processes
Render documents in the correct PDF format with auto-generated TOCs and appendices based on your content plan
An overview of the FDA medical device registration process, including how to classify a device and which submission process to use. This article covers the 510(k), PMA, and De Novo submission processes, and provides links to resources with additional information.