Track medical device regulatory intelligence for your products and markets

Get regular, up-to-date insight into the laws, regulations, guidance documents, and news that are most relevant to your business

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Track medical device regulatory intelligence
A better way to access trusted regulatory information

Regulatory affairs professionals spend up to 50% of their time simply searching for information, a task exacerbated by constantly changing guidance, regulations, and standards. Even more challenging is the fact that they often don’t have confidence in the information they find.

Rimsys provides regularly updated access to trusted information sources that you can curate to match the products and markets you care most about. Automatic alerts keep you in the loop when regulations or standards change.

Medical device regulatory intelligence software from Rimsys

Entrance requirements for 50+ countries
Curated regulatory newsfeeds

Receive relevant daily regulatory news updates directly within the Rimsys platform

Advanced intelligence from Clarivate
Market entrance requirements

Find requirements, costs, timeline, and other critical information your team needs for success submissions for over a dozen countries

Daily updates
Pre-built government templates

Use digital templates for FDA, EU MDR/IVDR, and other regulatory agencies to guide submission and GSPR/Essential principles authoring

Automatic monitoring and alerts
Automatic monitoring and alerts

Get notified about changing guidance, regulations, and international standards

Product impact tracking
Impact assessments

Associate standards and regulations with specific products and survey registration owners to assess the impact of changes


MDSAP - the ultimate guide to the medical device single audit program

Thinking about an MDSAP audit? Our guide provides an overview, pros and cons of MDSAP vs Regulatory Authority inspections, and audit sequence and grading.

MDSAP - the ultimate guide to the medical device single audit program
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