Where clinical evidence meets the story that makes it believable.
The U.S. Food & Drug Administration recently issued warning letters to Philips that underscore major vulnerabilities in device quality-systems and the downstream implications for risk management, product remediation, and market credibility. For medical-device...
Ever since COVID-19 was declared by the WHO a global pandemic, medical device and in vitro diagnostics manufacturers were scrambling regarding MDR and IVDR readiness. COVID-19 has introduced significant impacts that affect product development timelines, including...
With the implementation date of EU MDR fast approaching (2020) for all Class 1-3 devices, notified bodies are having a difficult time meeting and receiving MDR designation status. The European Union projected that 20 notified bodies would become MDR designated by...