LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to a varied suite of regulatory compliance solutions and services to support medical device manufacturers, distributors, and related operations. Reed Tech now helps remediate medical device UDI systems and processes in addition to providing machine-machine submissions to global health authorities (US FDA, EU EUDAMED, China NMPA, South Korea IMDIS, Australia AusUDID and others).

“We have found that our customers often have a need for regulatory expertise for specific, niche, compliance tasks. Global health authorities are instituting requirements that are often nuanced, requiring varying levels of clarity. To address and simplify the regulatory submission process for our clients, Reed Tech is expanding services beyond general Unique Device Identification (UDI) and device registration to include Regulatory Compliance Advisory Services.  Paired with our UDI submissions platform, SingleSource™ for Medical Devices, we are now a full-service medtech regulatory compliance solution,” said Wendy Scott, Head of Life Sciences Professional Services, Reed Tech. “This new service will offer a more complete regulatory solution for our medical device customers, as well as potential new customers, in one place, increasing efficiency while managing the product regulatory approval process.”

The medtech compliance expansion was developed with large and small life sciences companies in mind, to increase the efficiency and value that Reed Tech can provide.

“This expansion aligns with our mission to help customers focus on developing life-saving innovations while we act as an extension of their regulatory team, completing compliance tasks for them. Complimentary services like US Agent, API integration, UDI Compliance training and gap assessments are just a few of the offerings that can be sourced to Reed Tech, allowing companies to focus on other priorities.”

Reed Tech currently supports medical device, cosmetic and pharmaceutical companies, contract research organizations (CROs), labelers, distributors and other stakeholders preparing regulatory submissions.