Rimsys

Founded 2017

Manage medical device registrations, submissions, and regulatory compliance across global markets

You can use Rimsys to manage medical device regulatory operations, submissions, and product registrations worldwide. It centralizes product data, global market access intelligence, and regulatory change tracking in a single environment. Teams can evaluate market entry pathways, assemble and publish regulatory submissions, and manage Unique Device Identification requirements. The system also tracks standard updates and registration expirations across different countries, alerts stakeholders to upcoming renewals, and connects with existing enterprise systems to keep compliance data accurate and audit-ready across medical device lifecycles.

What Rimsys does

Track product registration lifecycles and expiration datesDraft and assemble medical device submission documentsConduct regulatory change impact assessmentsUpload and validate UDI data to global databasesMap device specifications to country-specific regulatory requirementsExport regulatory compliance metrics to business intelligence dashboardsCoordinate review tasks among regulatory affairs team membersTrack global medical device registrations across multiple countriesPlan, author, and track regulatory submissionsManage Universal Device Identification (UDI) data for FDA and EU complianceAssess regulatory impact across products and submissions before making changesAutomate renewal and expiration reminders across global jurisdictionsDirect integration with EUDAMED and FDA GUDID databasesEvaluate market entry pathways, classifications, and costs with guided regulatory intelligence

Frequently asked

EUDAMED, GUDID

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