Proactively monitor and manage medical device standards

Track any medical device standard and assess the impact of changes on your product portfolio

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monitor and manage medical device standards
Move past manual standards tracking

Maintaining international standards compliance can help ease market entrance, but it can come at a high cost. Keeping track of hundreds of standards, identifying changes, and understanding how they impact specific products is time-consuming, and simply hard to do effectively. Standard information ends up as siloed “tribal knowledge” known only to specific team members and lost with employee turnover.

Rimsys automates standards management, allowing RA teams to build customized libraries, get alerted when standards change, and proactively respond to prevent non-compliance or audit risks.

Medical device standards management software from Rimsys

500,000+ standards from 200+ organizations
500,000+ standards from 200+ organizations

Search our library of standards from over 200 organizations to find the ones you want to follow

Customizable, collaborative standards library
Customizable, collaborative standards library

Curate a library of standards that are relevant to your product portfolio, and share across teams

Product-level associations
Product-level associations

Link standards to individual products to easily assess the impact of changes across your product portfolio

Direct links to essential principles tables
Direct links to essential principles tables

Pull relevant standards information directly into your essential principles/GSPR tables for easier creation and maintenance

Automatic monitoring and alerts
Automatic monitoring and alerts

Get notified of changed, superseded, withdrawn, and work-in-progress standards

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5 signs you are ready to take your medical device regulatory team digital

The medical device industry is in dire need of robust, practical and easy-to-use software to make regulatory professionals’ lives easier.

5 signs you are ready to take your medical device regulatory team digital
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