The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.
The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.
NAMSA announced today its acquisition of CRI, a German-based full service CRO providing the European MedTech market with complete clinical research solutions to accelerate scientific outcomes to clients.
Compliance functions and processes gain respect and recognition when something goes wrong, prompting us to question “how and why” it happened. These questions were asked after the Challenger space shuttle disaster in 1986. Several factors contributed to the disaster. NASA managers were eager to launch the Challenger due to competition with the European space agency … Continued