Regulatory Reporting Software for Medical Device Manufacturers

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

Country-specific regulatory reports

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

Registration documentation

Access documentation that can assist your registration.

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

Streamlined submissions

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

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.

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

Regulatory guides

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

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.