EUDAMED Connector

Onboard, transform, and validate device data to automate M2M submissions to EUDAMED.

EUDAMED Connector
ATRIFY Connector

Transform, validate, and synchronize GDSN-compliant product data with your trading partners via atrify.

ATRIFY Connector
Success Story
Success Story

B. Braun implemented Innovit’s EUDAMED Connector to automate UDI submissions, enabling data onboarding from SAP, native EUDAMED-compliant data validation, and secure machine-to-machine data exchange with EUDAMED.

Featured Article
EUDAMED Compliance Guide for Device Manufacturers

Get practical, step-by-step guidance that translates regulatory and database requirements into actionable tasks that help you prepare, validate, and submit compliant device data to EUDAMED.

Featured Article
Celebrating 25 years of Bringing quality to master data!

Read a special note from Bang Chau reflecting on 25 years of bringing quality to master data, celebrating our journey, milestones, and continued commitment to data excellence in healthcare.

Case Study

Meeting FDA GUDID and GDSN Deadlines: A UDI Compliance Success Story

B. Braun accelerates global UDI and GDSN compliance

The Company

B. Braun is one of the world’s leading medical technology companies, developing medical devices, pharmaceutical products, and healthcare solutions that help healthcare professionals deliver safe, effective, and efficient patient care.

With operations in more than 60 countries, B. Braun offers a broad portfolio of products spanning infusion therapy, surgery, orthopedics, pain management, dialysis, vascular access, and infection prevention, making it one of the largest and most diversified suppliers to the global healthcare industry.

3

Data pools (atrify, GHX and NPC)

<8 months

GUDID implementation timeline

>85%

Cost savings per market

The Challenge

B. Braun needed to support a growing global business across more than 60 countries while managing an expanding portfolio of healthcare products. This required a consistent approach to maintaining, validating, and publishing trusted product information to meet both regulatory and commercial requirements.

In addition to complying with the FDA’s Unique Device Identification (UDI) regulations, B. Braun needed to synchronize standardized product information with trading partners through multiple GDSN data pools, including atrify, GHX, and the National Product Catalogue (NPC).

The company faced several challenges:

  • Product data was not consistently synchronized with regulatory agencies and trading partners.
  • Product information lacked standardized governance across global markets.
  • Publishing and maintaining product data required significant manual effort.
  • Multiple regional requirements increased the complexity and cost of expanding into new markets.

“We were at risk to miss the UDI Class II deadline of September 2016 and our team in Australia suggested Innovit. After an extensive RFP process involving numerous solutions, the path forward was clear.”

The Solution

Following an extensive evaluation process, B. Braun selected Innovit’s cloud-based UDI and GDSN solutions to establish a standardized platform for regulatory submissions and global product data syndication.

Key requirements included:

  • A flexible and extensible product data model
  • Certified GDSN connectivity supporting multiple data pools
  • Native FDA GUDID connectivity
  • Built-in data validation and reporting capabilities
  • Rapid implementation to meet FDA UDI compliance deadlines

Innovit’s solution was integrated with B. Braun’s internal systems, providing a unified global process for managing regulatory and GDSN publication activities across multiple markets.

The Results

Within eight months of project kickoff, B. Braun successfully implemented the solution and began submitting UDI data to FDA’s GUDID, meeting critical regulatory deadlines. The implementation was subsequently extended to support product data publication through multiple GDSN data pools, including atrify, GHX, and NPC.

The solution was deployed across the United States, Canada, the United Kingdom, the Netherlands, Australia, and New Zealand, with the goal of adding remaining markets in France, Germany, Italy, Spain and Switzerland shortly after.

By establishing a reusable template for global product data syndication, B. Braun significantly reduced the effort and cost required to onboard new markets. Standardized data validation, transformation, and publication processes enabled efficient regulatory submissions and GDSN data syndication, while eliminating the need for market-specific customization and expensive consulting services.

“We expanded to the UK and Netherlands market at fraction of cost when compared to our initial efforts in America and Canada, resulting in a net savings of more than 85% per market.

Innovit helped us overcome so many challenges by allowing us to implement a global system and unified process that’s fully integrated with our internal systems.”

ACCESS NOW

View the Full Content

Fill out the form below to gain access to the full content.

Share This Content

Explore More

Continue exploring related content and deepen your understanding

B. Braun Streamlines UDI Data Submission to EUDAMED with Innovit EUDAMED Connector
Blog

B. Braun Streamlines UDI Data Submission to EUDAMED with Innovit EUDAMED Connector

UDI Implementation Methodology
Datasheet

Innovit’s UDI Implementation Methodology for Rapid Time-to-Compliance

GUDID Connector Datasheet
Datasheet

Innovit GUDID Connector

Ready To Get Started?

Partner with Innovit for Faster Time-to-Value

Join leading device manufacturers and healthcare organizations who trust Innovit to manage their most critical product data.
Schedule a discovery session to address your specific UDI compliance, GDSN syndication, or PIM/MDM requirements
Understand how Innovit integrates into your specific IT environment and timelines to ensure rapid time-to-value 
Explore our SaaS capabilities through a hands-on trial environment