Reed Technology and Information Services, a leader in data management and analytic services and solutions for the Life Sciences industry, announces the launch of Reed Tech SingleSource for Medical Devices.
Image: Reed Tech introduces Reed Tech SingleSource. Photo: Courtesy of Markus Spiske/Pixabay
It is a new global solution for medical device manufacturers to manage regulatory and commercial product information. SingleSource for Medical Devices manages and reports regulatory Unique Device Identification (UDI) information to health authorities worldwide and publishes commercial product information to trading partners from a centralized platform.
In today’s global marketplace, Regulatory Affairs professionals increasingly need subject matter expertise to navigate, understand and react to the regionally specific nuances of the electronic submission process. “We are seeing a tsunami of medical device UDI regulations being enacted around the globe, and our customers have asked how we can help. We do the heavy lifting of constantly monitoring UDI-related regulations and we pore through the detailed technical specs and feed that knowledge into our system design so our customers can focus on doing their core jobs without feeling overwhelmed,” said Arshad Rahman, General Manager of the Reed Tech Life Sciences division. “In an increasingly complex world, our SingleSource for Medical Devices provides an affordable, scalable, global solution that helps our customers manage and distribute valid product information to global UDI data recipients.”
For medical device manufacturers, Reed Tech provides UDI specific solutions, services and expertise, reducing the internal burden in navigating the required business rules for validating, managing and submitting to regulatory agencies. The SingleSource system is a Reed Tech hosted, online repository with governance and controls for data quality, data integrity and data security. This global solution can seamlessly act as a “single source of truth” allowing medical device manufacturers to confidently and efficiently distribute accurate product UDI data to multiple regulatory agencies and commercial partners throughout the world, each with different regional requirements, or it can integrate with existing PIM/MDM systems and provide the “last mile” support.
Using experience gained over a decade as a leading UDI information supplier to the FDA (submitting close to one-quarter of all industry UDI records), Reed Tech designed the SingleSource for Medical Devices system to manage UDI data throughout the product lifecycle in a compliant SaaS environment and included scalability for additional volume and data channels. As the number of global entities requiring medical device UDI information grows, Reed Tech will add selectable channels for data submission to regulatory bodies and data syndication to commercial trading partners. Strategic product data management supported by a deep understanding of medical device regulatory and user UDI data requirements will ultimately contribute to improved outcomes for both healthcare providers and patients.
Reed Tech will roll out implementation and submission phases through 2019 in anticipation of the EU Medical Device Regulation (MDR) UDI submission deadline of May 2020.
Source: Company Press Release