osapiens for Medical Devices
(BYRD Health)
Efficient Medical Device Data Management
Manage medical device and product data with ease, ensure compliance with global regulations, and seamlessly share them with hospitals, purchasing groups, and marketplaces. The osapiens for Medical Devices (BYRD Health) ensures digital, automated, and quality-assured processes for the healthcare, medical and pharmaceutical sectors in a validated environment.
Our Product Portfolio
EUDAMED
- The BYRD Health platform allows companies large, medium and small to meet EUDAMED data synchronization requirements.
- We enable simple API or XML over AS/2 machine-to-machine connections; typically for companies with larger product counts and/or frequent product content changes.
- For mid-sized and smaller companies, we provide a simple .xslx document that you fill with the product information, likely extracted from your ERP, PLM, RIMS or other applications. You easily upload this data to the BYRD platform and syndicate the products to EUDAMED, viewing and managing all status issues in the BYRD platform. A key entry is also available.
Either way, your project will be guided by the most experienced team in the industry. We help you understand, attribute by attribute, what is required and how to meet those regulatory requirements.
If you have done a US FDA GUDID project before, we can help you understand the significant differences in structure and requirements between the two, including understanding and meeting EUDAMED data structures with BUDI.
Contact us today for a demo or to discuss the best project plan for your organization.
EUDAMED Compliance Made Simple – Your Guide to Successful Implementation
Get a clear and practical overview of the EUDAMED requirements and processes. Learn how to meet regulatory demands efficiently and benefit from digital support.
What is osapiens for Medical Devices (BYRD Health)?
In the healthcare sector, managing product information requires navigating complex data formats and protocols for internal use, data exchange, and compliance with stringent quality standards in a validated environment. Enabling trusted healthcare through seamless data exchange, osapiens for Medical Devices (BYRD Health) facilitates the syndication of medical device data from manufacturers to regulatory databases and trading partners worldwide. Regulations and standards like COVIN, GDSN, EUDAMED, GUDID, LIR, US FDA and others are designed to enhance data quality, ensure measurability, and support electronic processes for quality-assured management.
Twice as fast to go-to-market
osapiens for Medical Devices (BYRD Health) streamlines the transfer of medical device data, ensuring seamless exchange between manufacturers, regulatory databases, and trading partners worldwide. The BYRD data integration solution helps you manage product information effortlessly, while the BYRD connector solution ensures compliance by automatically aligning your data with the required formats of global regulatory authorities. Eliminate friction in your data exchange and gain the trust of your partners and customers.
Flexible and automated
Ensure your data reaches regulatory authorities and business partners in the correct format — without manual effort.
Trusted In-House Industry Experts - Guiding You Every Step of the Way
Security
Our validated environment and stringent security measures ensure that you have a secure and compliant process that meets QMS requirements for registering and exchanging your UDI data with your trading partners.
Challenges
Varying regulatory databases
Each regulatory authority has its own database and medical device manufacturers have to satisfy different data formats, data structures, etc.
Complex product data upload
The data provision via the interface of regulatory authorities is complex, error-prone and lacking any customer experience.
Consistent product data
Providing consistent data to all stakeholders (e.g., users, hospitals etc.) is key to maintain trust in the medical device.
Syndication to Federal UDI Registries
BYRD – the platform for medical device data
The BYRD platform supports multiple methods of data transfer, including Machine to Machine (XML via AS/2, API , JSON), Excel uploads, and manual entry. The BYRD platform allows you to manage your data and Syndication in 1 place connecting you to GS1/GDSN, EUDAMED, FDA GUDID, GUID, TGA Australia, Swissmedic, Emirates Health Services (EHS), Dubai Health Authority (DHA) and others.
We are committed to providing connectivity from BYRD to all Federal Entities with UDI databases. In the future, when the Regulatory bodies establish their programs we expect to provide connectivity to Colombia/INVIMA, Brasil/ANVISA, UK/NHS & MHRA, Canada, Singapore, and Brazil.
Products and Services
osapiens for Medical Devices (BYRD Health) supports the entire Product Content Life Cycle Management
Aggregation
Content and product data aggregation within the osapiens for Medical Devices (BYRD Health) solution allows you to centrally manage all required product information and keep it globally compliant. By aggregating your data, you ensure that your products meet all regulatory requirements - efficiently and error-free.
Benefits of aggregating product data:
- Full compliance: meet all UDI requirements worldwide.
- Central administration: Optimize data maintenance and reduce errors.
- Faster market approval: Shorten time to market with standardized data
- Increased transparency: Ensure traceability and traceability.
Take advantage of centralized data aggregation and ensure efficient and compliant management of your medical devices. Stay UDI-compliant and maximize your efficiency!
Technology Integrations and Partner
osapiens for Medical Devices (BYRD Health)
Trusted by hundreds of companies from all industries
Success Stories
PAJUNK – Clear route to healthy product content
Medical technology manufacturer PAJUNK® automates its product information management with BYRD services and solutions.
White Paper
PIM in the healthcare industry
Nowhere else is quality-assured product information as important as in the healthcare sector. For manufacturers, purchasing groups, and other market participants, there are stringent requirements that can only be met with the right technology and optimised processes.
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