Device Regulatory Excellence

Embedding Regulations as an Asset, not Overhead

Gaining the right product approvals and certificates for major markets is fundamental to both succeed and to ensure safety and effectiveness of every medical device. Properly defined and prepared submission reports help assure that the submission contains the appropriate defined information requested by the various regulatory bodies for the specific product classification. For example, the collection of products and key UDI attributes from a company’s systems can be automatically bulked to refine and reuse data for UDI submission and approvals.


Licensed to Cure for Medical Device solution (link to ENOVIA’s Global Market Registration) breaks the silo barriers within a company to create a more unified approach to taking a product to market, therefore significantly decreasing time to market. It allows companies to eliminate scattered processes and data and to “embed” regulations as an asset, optimizing and controlling the management of highly-regulated business processes for worldwide submissions and approvals.

Key Benefits:

  • Realtime collaboration
  • End to end consistency
  • Seamless dossier completeness
  • Time to market authorization delay reduction
  • Timely and traced regulatory answers
  • Full consistency between submission and actual product design
  • Submission effort reduced thanks to IP direct reuse
  • Actual product data reused for DI submission

By leveraging the 3DEXPERIENCE platform that combines engineering, quality, and regulatory compliance business processes, we have moved closer towards becoming the R&D and manufacturing center of choice for our customer.

Lim HN Olympus Technologies Singapore