Medical device professionals face an ever-growing list of demands for their product data from downstream users all over the world. Some of these demands are regulatory, such as FDA’s Unique Device Identification (UDI) submission mandate.
Others are commercial, such as hospital networks needing access to device product data electronically through the Global Data Synchronization Network (GDSN) in order to maintain a current product catalog. Still other requests may come from a governmental body, not as a regulatory mandate, but as prerequisites for doing business with that agency, such as the NHS eProcurement initiative in the U.K.
These ends users require unique, but overlapping, datasets for every device product. But treating each data submission type as a separate project and ensuring changes and updates get passed along to each recipient can quickly become an unmanageable task.
Together, Reed Tech and 1WorldSync offer device manufacturers a solution to meet the challenges of securely managing all of this data, ensuring it is accurate and up-to-date, and sharing it with the downstream users who need it.
A combined solution from Reed Tech and 1WorldSync brings individual organizational strengths into a single, comprehensive solution bringing you benefits you wouldn’t reap from working with just one of the providers:
- Secure, centralized storage of your product data in a fully validated Reed Tech environment built just for device manufacturers and conforming to 21 CFR Part 11 requirements.
- Transparent control over the state of each record with instant reports and a complete audit trail.
- Access to the GDSN through 1WorldSync, the leading provider of product content solutions and largest certified data pool provider.
- Support by experts from both organizations, through a single point of contact at Reed Tech.
- Straightforward, competitive pricing and a combined agreement for an easier purchasing process.
- Peace of mind with a global roadmap to meet upcoming requirements, including the UDI requirements of EU MDR.
Whether it’s the FDA, NHS in the U.K., GPOs or hospital networks, you can know that the information about your product reaching the recipient is accurate and current.