FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline

Q&A: Is GDSN a Viable Option to Submit Data to EUDAMED?

EUDAMED timelines are quickly approaching, and UDI data preparation is no easy task.   Preparing early with a master data strategy will make all the difference when mandates for EUDAMED and other health authorities come due.  A large component of that strategy centres...
EUDAMED Implementation and Roll-Out Timeline Update

EUDAMED Implementation and Roll-Out Timeline Update

The European Commission recently sent out an update on the plan for implementation and roll-out of EUDAMED, as it stands today. Changes to the implementation timeline of different modules, and how they will affect the application of each aspect of MDR are outlined...
The Importance of Healthcare Data Management

The Importance of Healthcare Data Management

Healthcare data management is an essential part of working in the industry. You’re not only legally obligated to manage patient healthcare. Patients’ health outcomes often depend on your ability translate, store, and transmit records properly. Managing...