NAMSA announced today its nearing acquisition of Medanex Clinic, a Belgium-based European preclinical research organization. Medanex’s robust preclinical capabilities and expertise, specifically in the Cardiovascular arena, will help enhance NAMSA capabilities and over Client experience.
Month: March 2022
NAMSA announced its intent to acquire ÅKRN Scientific Consulting, a prominent European Medical Device CRO based in Madrid, Spain. The acquisition of ÅKRN increases NAMSA’s global scale, now serving MedTech Clients across 19 locations throughout APAC, Europe, North America and South America.
Identifying the right model for a preclinical study can be a significant challenge. The choice often comes down to whether the model shares specific anatomical characteristics with the humans who will eventually be the end users of a particular medical device. Another consideration is the size of the model and how it accommodates a specific medical device.
On February 23, 2022 the U.S. Food and Drug Administration (FDA) published the proposed ruling of changes to the current 21 CFR part 820 – Quality System Regulation (QSR) and upon finalization, will be referred to as the ‘Quality Management System Regulation (QMSR).’ This ruling, among other changes, incorporates a significant shift incorporating by reference, the Quality Management System requirements of ISO 13485:2016.
ew Medical Device Coordination Group (MDCG) guidance document, MDCG 2022-4: “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD,” was published on the 16 February 2022. It provides information for both manufacturers and Notified Bodies (NBs) concerning the transition requirements for legacy medical devices.