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  • Software

Regulatory Reporting Software for Medical Device Manufacturers

Explore new markets with insights categorized by country, device type, and device class with RAMS® Regulatory Reports.

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Chart a course. Get on market. Drive success.

Medical device manufacturers can’t afford a one-size-fits-all approach to market expansion. To scale your success, you must navigate unique regulatory requirements in each market. RAMS is your go-to resource for defining your regulatory roadmap.


Get valuable insights into regulatory requirements with regulatory reporting tools for medical device manufacturers

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Country-specific regulatory reports

Understand how regulatory bodies operate in each country and how devices are classified.

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Registration documentation

Access documentation that can assist your registration.

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In-country representation

Locate requirements and resources for in-country representation, importers, and distributors.


Make your road to market faster with fewer worries and streamline regulatory submissions with RAMS Regulatory Watch

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Streamlined submissions

Reduce the time and cost of approval by by making submissions more compliant and decreasing likelihood of denials.

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Device submission assistance

RAMS walks you through the approvals process for medical device and IVD submissions with detailed step-by-step instructions tailored to each device class.

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Regulatory intelligence

Get market intelligence on dossier requirements, clinical data requirements, testing, labeling, and quality management system needs.


Stay on market post-approval and meet global regulatory requirements for medical devices

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Regulatory guides

RAMS Regulatory Reports include detailed post-approval guides for each market to avoid costly business interruptions.

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Market-specific guidance

Get the guidance you need for each market to understand import requirements, post-approval renewals, how to address product changes, post-market surveillance, and recalls or safety concerns.



Take control of your regulatory affairs today

Create your complimentary account and see why RAMS is trusted by medical device companies all over the world.

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Get answers about registering and renewing accounts and what tools you’ll find in RAMS.


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