Clinical trials are essential for evidence-based medicine, providing critical insights into the efficacy and safety of new treatments. One crucial aspect of conducting clinical trials is the rando…
Regulatory Impact Assessment (RIA) need not be fully integrated into the regulatory policy processes from the beginning. Companies can start by undertaking RIA for certain key regulations which ar…
Too often, small and mid-size companies are intimidated by the costs, complexity, and long implementations…
It’s possible to turn RA/QA into a smart function much faster and cheaper than most…
This draft guidance is intended to:
Computer Software Assurance is a risk-based approach to establish confidence in the automation used for production or quality systems, that software is fit …
Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to establish national language requirements for makers of device companion materials. …
