Articles – Resources – AKRN Social network
AUDITING A QMS ACCORDING TO ISO 13485
When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed,
EU MDR risk management requirements: FMEA and ISO 14971 comparison
Historically, medical device manufacturers have frequently used Failure Modes and Effects Analysis (FMEA) to identify possible failures in
NEW AEMPS INSTRUCTION FOR MANUFACTURING LICENSE
The new AEMPS instruction on the procedure to obtain the manufacturing licence is a long-awaited document for medical device (MD) and in vitro
DEVELOP AND IMPLEMENT YOUR QMS ACCORDING TO ISO 13485
Previously, we published an article introducing the basic concepts, definitions and requirements for Quality Management Systems (QMS) within the
AKRN Social Network