How Hybrid Audits Can Help MDR Compliance in the European Union
The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]
The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]
Corrective and preventive action (CAPA) is a core function in any quality manage [...]
Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]
Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]
RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]
The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]
Companies marketing devices in the European Union are facing a perfect storm of [...]
As innovation in medical technology increases, potential cybersecurity threats a [...]
The European Union (EU) Medical Device Regulation (MDR) officially went into eff [...]
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]