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Medical Device-Regulatory & Product Intelligence

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  1. Regulatory requirements for Devices, Diagnostics, Digital Health, SaMD, and Combinational products.
  2. Manually reviewed regulatory summaries covering clinical, technical, QMS/Quality, market launches, testing standards, submission checklists, fees, labeling, import/export, marketing, safety/Vigilance, life cycle requirements, and many more areas in a granular manner.
  3. Compare countries or specific areas side-by-side and download in the format of user preference.
  4. Global up-to-date technical standards and subscribe to alerts.
  5. 1.2 Million Global document repository of health authorities’ regulations and guidance updated daily and provided to you with AI-enabled search for faster and better matches.
  6. Global clinical trials gathered from global registries to see all clinical activity.
  7. Comprehensive Regulatory Intelligence report on all the Regulatory requirements including market trends and forecasts for a country
  8. Country-wise updates for Medical Devices and Diagnostics covering the Regulatory news and their anticipated impact and recommendations
  9. Timely alert to client in case any prompt action is required 
  1. Device Classification Name
  2. 510(k) Number
  3. Device Name
  4. Applicant
  5. Product Code
  6. Decision Date
  7. Decision
  8. Classification Advisory Committee
  9. Review Advisory Committee
  10. Device Summary