How osapiens Empowers the Medical Device Industry
For medical device manufacturers, complete and accurate product data are essential to meet both regulatory and commercial trading partner requirements. Regulations such as EUDAMED (European Commission) and GUDID (US FDA) require the submission of comprehensive product information to their respective databases before products can be marketed. This data forms the foundation of a safe and secure healthcare supply chain, enabling more reliable post-market surveillance and significantly improving patient safety.
The osapiens platform supports regulatory requirements including EUDAMED, GUDID, SFDA (Saudi-DI), TFDA (Taiwan), and the Netherlands LIR (via GDSN), as well as upcoming requirements from TGA Australia, Swissmedic, Emirates Health Services (EHS), and Dubai Health Authority (DHA).
By automating data exchange, osapiens reduces manual effort across the entire product lifecycle, streamlining compliance and improving operational efficiency.
Related Transparency Solutions
osapiens for Medical Devices (BYRD Health)
Simplify regulatory data management — ensure global compliance
Reliable product data is the foundation for compliance, patient safety, and successful market access in the MedTech industry. The osapiens solution for Medical Devices (BYRD Health) empowers manufacturers to efficiently collect, validate, maintain, and publish product data across key regulatory systems — including EUDAMED, GUDID, and healthcare data recipients such as GPOs via HCDP.eu.
With automated workflows, robust data validation, and real-time syndication, the solution helps you reduce manual effort, eliminate errors, and accelerate time-to-market — while ensuring compliance and data quality at every step.
- Centralized product data management
Aggregate and maintain all relevant product and content data in one place — ensuring accuracy, consistency, and global compliance.
- Seamless UDI compliance
Meet international Unique Device Identification (UDI) requirements and partner-specific rules, including validations through COVIN and HCDP.eu.
- Fast and accurate publication
Automate data formatting and submission to regulatory databases and healthcare partners — reducing manual updates and avoiding errors.
- Real-time product data distribution
Keep trading partners and healthcare data recipients always up to date through automated, global syndication.
- Reduced complexity, increased efficiency
Eliminate data silos, streamline compliance processes, and focus on innovation and patient care instead of administrative tasks.
Related Efficiency Solutions
osapiens HUB for Supplier Relationship Management
Manage supplier relationships
Gain full visibility and foster collaboration on key contracts and supplier performance to avoid stock-outs of critical supplies. With our Supplier Relationship Management solution, you can:
- Ensure Supply Chain Continuity
Strong supplier partnerships reduce the risk of stock-outs or disruptions—especially critical for high-demand medical devices, pharmaceuticals, and consumables.
- Reduces Risk Exposure
A clear overview of critical, high-risk, or single-source suppliers allows for better contingency planning and early detection of potential issues. Managing supplier certifications, audits, and performance data in one place ensures that all incoming products and services meet clinical and regulatory standards. Centralizing supplier interactions—from contracts to KPIs—helps departments align, resolve issues faster, and strengthen quality and compliance.
- Improve Cost Efficiency
Greater transparency into supplier performance and contracts supports stronger negotiations for hospitals and helps identify cost-saving opportunities. Strategic partnerships also encourage suppliers to co-develop solutions, improve lead times, and enable quicker responses to evolving hospital needs—whether for new technologies or service delivery models.
Back
