Navigating the intricate regulatory landscape of medical device compliance is a growing challenge for manufacturers. Ensuring patient safety, maintaining market access, and staying ahead of ever-evolving global standards requires both accuracy and agility.
To enable medical device companies to tackle these challenges head-on, Informatica and BYRD Health have partnered to streamline compliance efforts through a powerful combination of Informatica Product 360 and the BYRD Health Accelerator.

This collaboration offers medical device companies a faster, smarter route to regulatory alignment – especially with systems like EUDAMED (EU) and GUDID (U.S. FDA) – slashing compliance timelines from years to just a few months.

EUDAMED (European Database on Medical Devices) and GUDID (Global Unique Device Identification Database) are central to the medical device regulatory frameworks in Europe and the United States. These databases are designed to enhance transparency, traceability, and post-market surveillance, ensuring patient safety and regulatory oversight.

To remain compliant, medical device manufacturers must submit detailed product information – typically between 70 to 150 data attributes – including:

• Device identifiers
• Device characteristics
• Intended use and labeling
• Manufacturing and production
• Regulatory information

Failure to comply with EUDAMED and GUDID regulations can be catastrophic. Medical device companies that miss regulatory deadlines risk losing access to critical markets, potentially forfeiting 60–80% of their revenue. With the EU’s EUDAMED compliance deadline approaching in January 2026, the clock is ticking for manufacturers to act.

The joint solution offered by Informatica and BYRD Health provides a centralized, pre-configured, and scalable platform for seamless regulatory data management. By combining Informatica’s Product 360 with the BYRD Health Accelerator, companies can create, maintain, and syndicate regulatory data across both EUDAMED and GUDID – all from a single platform.

Key Features

• Pre-configured Data Models
  Built-in templates aligned to GUDID and EUDAMED regulatory requirements.
• Streamlined Communication Exchange
  Seamless integration between Product 360 and BYRD Health, supporting communication with regulatory authorities.
• Data Validation and Quality Checks
  Validation and quality rules to ensure data completeness, accuracy, and compliance with regulatory requirements
• Pre-Built Submission Dashboards
  Real-time visibility into the status of regulatory submissions across systems.
• Reference Data Management
  Maintenance of required industry-specific code lists and mappings to internal data.
• Audit Trail and Change Management
  Maintenance of detailed audit log of all data changes, user actions, and submission events.

Traditionally, regulatory compliance implementations can take up to two years. This partnership reduces that time to just three-to-six months through automation, standardization, and advanced data governance.

Without this solution, manufacturers would need to:

• Build custom databases for each market
• Design localized communication protocols
• Develop separate user interfaces
• Navigate multiple FDA/UC validations
• Identify and manage regulatory-specific code lists manually
• Map internal data to industry standards

With Informatica and BYRD Health, all of this is streamlined – creating time for teams to focus on innovation and patient outcomes instead of compliance bottlenecks.

As global regulatory expectations grow increasingly complex, forward-thinking manufacturers are turning to digital solutions to future-proof their compliance strategies. Informatica Product 360 and the BYRD Health Accelerator offer a robust, scalable path to continuous compliance, helping companies navigate the regulatory landscape with speed and confidence.

Ready to streamline your regulatory compliance process?
Contact Informatica to learn how our solutions can accelerate your path to market and reduce compliance risk.