Identifying and Mitigating Common Bottlenecks in Pharmaceutical Documentation
As you likely already know, pharmaceutical companies operate within a rigorous regulatory framework where precision, accuracy, and timeliness in documentation are crucial. Yet, the regulatory submission process is often hindered […]
The Impact of MDCG 2024-10 on Internal Processes, Timelines, and Team Readiness
The introduction of the MDCG 2024-10 guideline in June 2024 marks a significant shift in how orphan medical devices are evaluated and brought to market in the European Union. This […]
The Impact of the IVDR on IVD Clinical Performance Studies
With the full implementation of the In Vitro Diagnostic Regulation (IVDR) in the European Union, the landscape for clinical performance studies involving in vitro diagnostic (IVD) devices has undergone significant […]
