Pharma IT

May 4, 2023

SaMD (Software as a Medical Device) and Reflecting on EU MDR Compliance 

Diagnosing illnesses and monitoring health is increasingly reliant on utilizing software. For patients, manufacturers must maintain standards and regulations. Companies can be concerned with challenges concerning updated legislation such as the EU’s MDR.  Companies have increased importance on determining whether their software is categorized as a medical device, as well […]
August 18, 2023

COVID-19 and Pharmacovigilance Findings from EMA and MHRA

The drug safety environment is heavily regulated and continuously evolving, with numerous compliance challenges. Since the start of the COVID-19 pandemic, many pharmacovigilance monitoring activities have taken place remotely. Insights gleaned from these reports can help companies remain compliant when conducting pharmacovigilance during COVID-19 and beyond.