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
- Understand how regulatory bodies operate in each country and how devices are classified.
- Access documentation that can assist your registration.
- Locate requirements and resources for in-country representation, importers, and distributors.
Make your road to market fast and worry-free
- Reduce the time and cost of approval by getting it right the first time and eliminating denials.
- RAMS walks you through the approvals process for medical device and IVD submissions with detailed step-by-step instructions tailored to each device class.
- Get market intelligence on dossier requirements, clinical data requirements, testing, labeling, and quality management system needs.
Stay on market post-approval
- RAMS Regulatory Reports include detailed post-approval guides for each market to avoid costly business interruptions.
- Get the guidance you need for each market to understand: import requirements, post-approval renewals, how to address products changes, post-market surveillance, and recalls or safety concerns.
