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Master Data Management and Validation to Meet Global Requirements

An Introduction to Computer System Validation

USDM helped a medical device customer to execute their Master Data Management (MDM) process to prepare for the EU MDR deadline

Learn how USDM’s expert product data consultants were able to help the customer scale their approach to anticipate new global regulatory requirements that will follow the EU MDR deadlines. USDM also handled the validation of the customer’s new product data system and currently manages updates by ensuring continuous cloud compliance through USDM’s Cloud Assurance for Oracle.

The Situation
  • A large medical device and diagnostics company
  • The company needed to meet new regulations in the US and EU for Unique Device Identification (UDI) regarding product labeling and submissions to protect more than $15B in annual revenue
  • Three global business sectors and ten individual operating units managing siloed data sets
  • The company needed a holistic, global solution to collect, store, maintain, and publish data in a validated environment
The Solution
  • USDM consulted with the customer to execute their MDM process for various global agency requirements
  • USDM created a plan to address the immediate requirements for the US and EU while ensuring the plan was scalable to new, global regulatory agency requirements
  • USDM helped to set up a new, more flexible environment to collect, store, and publish product identification data to medical agencies within the companies Oracle Product Data Hub cloud-based system
  • USDM validated the Oracle cloud system and maintains continuous compliance by managing all new updates though USDM’s Cloud Assurance for Oracle service

The Results

  • Delivered a sustainable MDM plan on time​
  • Revamped data definitions, structures, and system requirements​
  • Achieved a scalable solution for new regulatory requirements that arise

Learn more about USDM’s solutions for the medical device industry.


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