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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.
Search our library of standards from over 200 organizations to find the ones you want to follow
Curate a library of standards that are relevant to your product portfolio, and share across teams
Link standards to individual products to easily assess the impact of changes across your product portfolio
Pull relevant standards information directly into your essential principles/GSPR tables for easier creation and maintenance
Get notified of changed, superseded, withdrawn, and work-in-progress standards
ISO 13485:2016 defines quality management system (QMS) requirements for organizations producing medical devices. ISO 13485 compliance is required for most medical devices by all European Union members, UK, Canada, Japan, Australia, and many other countries.