osapiens for Medical Devices – BYRD Health, a leading provider of medical device data syndication and UDI product data compliance solutions, has officially achieved Cloud Assurance Certification from USDM Life Sciences, reinforcing their shared commitment to quality, compliance, and innovation in the life sciences industry.

Cloud Assurance Certified: A Trusted Badge for GxP Technology

USDM’s Cloud Assurance Certification is a rigorous program designed to help life sciences companies identify technology vendors that meet the strictest global regulatory requirements. Certified vendors undergo comprehensive assessments for GxP compliance, data integrity, cybersecurity, and software quality assurance across development, testing, and release processes.

For osapiens for Medical Devices – BYRD Health, this means:
– A validated environment for UDI data submission to the FDA’s GUDID, EUDAMED, TGA, GDSN, etc.
– Ongoing release management and compliance monitoring
– An annual USDM audit to maintain continuous compliance

BYRD Health joins dozens of other leading technology vendors that have achieved Cloud Assurance Certification from USDM, including Oracle SCM, Google Cloud, PTC Vuforia, and other GxP-ready platforms committed to supporting continuous compliance in the life sciences industry.

“BYRD Health exemplifies what it means to be a trusted technology partner in today’s complex, data-driven regulatory landscape,” said Jay Crowley, VP of Medical Device Solutions at USDM. “With Cloud Assurance Certification, they are not only helping customers efficiently achieve UDI compliance, but they are also accelerating readiness for evolving global UDI mandates, including EUDAMED.”

The Power of Partnership: Enabling Life Sciences Organizations Worldwide

Together, BYRD Health and USDM deliver a comprehensive UDI compliance solution that includes regulatory guidance, product identification strategic consulting, UDI data collection and submission and a validated environment with change management support. This collaboration empowers medical device manufacturers to modernize their compliance strategy, reduce regulatory risk, and improve operational efficiency.

The osapiens for Medical Devices – BYRD Health platform serves as a central hub for sourcing, aggregating, and syndicating product data to regulators and trading partners—enhancing data accuracy, traceability, and transparency across the supply chain.

About osapiens for Medical Devices – BYRD Health

BYRD Health, an osapiens company, provides a best-in-class platform for syndicating medical device data from manufacturers to regulatory authorities and trading partners. With its deep domain expertise and integrated approach, BYRD Health enables organizations to enhance data quality, meet evolving global UDI regulations, and support safe, transparent healthcare delivery.

About USDM Life Sciences

At USDM Life Sciences, we empower life sciences organizations to drive innovation through intelligent operations. By integrating AI, automation, and digital quality systems, we help biotech, pharma, and medical device companies deliver transformative results. Trusted by global technology leaders and life sciences organizations alike, we ensure seamless alignment between compliance and cutting-edge innovation. With tailored solutions that evolve regulated tasks, we enable our customers to achieve measurable outcomes with agility and confidence. For more, visit www.usdm.com.