Partnership

Bayard Consulting

Bayard and USDM have the knowledge and experience to manage EUDAMED submissions ahead of the 2026 deadlines and address the other regulatory regions that already require or will soon require similar UDI submissions.

USDM UDI Services

USDM has helped more than 100 medical device companies achieve a UDI-ready state with services like:

  • Global UDI Regulatory and Program Planning
  • QMS Revisions
  • Label, DM, IFUs, Packaging Reviews and Guidance
  • Data Collection, Cleaning, MDM, Maintenance and Submissions
  • UDI MDM and Submission Apps Implementation
  • Validation and Release Management
  • New Regulation and New Agency Planning and Support

Bayard provides data syndication services to regulatory agencies and healthcare companies and lays the foundation for digital transformation. They have unparalleled experience in product content management, extensive expertise in implementing its enterprise Product Information Management (PIM) solution for product content management, and managing and submitting UDI data to the regulatory agencies on the BYRD platform.

Bayard Combines Organization, Processes, and IT

The requirements for product information in healthcare include data formats and protocols for transmitting product information within your organization, creating and maintaining product information, and maintaining data quality. Managing the quality of your product information is accomplished by appropriate organization, processes, and IT.

Watch the on-demand webinar Mandatory Use of EUDAMED Now Starting Q1 2026 co-hosted by Bayard’s Lionel Tussau and USDM’s Jay Crowley.

BYRD enables life sciences companies to generate the greatest possible business value from their product content using out-of-the-box, turn-key industry packages developed by Bayard’s product content experts. It’s the ideal solution for sourcing, aggregating, syndicating, and exchanging product content. BYRD users can easily exchange data via the Global Data Synchronization Network (GDSN).

How USDM and Bayard Support Medical Device Manufacturers

As a trusted partner of Bayard, USDM delivers continuous cloud compliance and ensures that your QMS strategy keeps your global operation compliant. Our Cloud Assurance service enables your organization to meet FDA 21 CFR Part 11, European Commission Annex 11, UDI, and other regulatory requirements for life sciences organizations. As a trusted partner of Bayard, USDM delivers continuous cloud compliance and ensures that your QMS strategy keeps your global operation compliant. Our Cloud Assurance service enables your organization to meet FDA 21 CFR Part 11, European Commission Annex 11, UDI, and other regulatory requirements for life sciences organizations.

To deliver a successful BYRD platform implementation, USDM Cloud Assurance uses application testing and regression testing to deliver end-to-end GxP compliance from implementation through ongoing validation maintenance and new releases. A Cloud Assurance subscription includes: 1) an annual BYRD audit, 2) the initial validation of your BYRD platform, and 3) ongoing release management to keep you continuously compliant.

USDM’s annual audit of BYRD saves you time and money. It assesses BYRD’s software development lifecycle (SDLC) and software quality engineering activities for the design, development, testing, validation, and release.

Contact us to learn how this partnership supports your organization’s UDI data and EUDAMED registration efforts.