Archive for December 14th, 2015

Effective Change Management in Medical Device Manufacturing

Change is an inherent part of the lifecycle of a medical device. It can affect all aspects of Current Good Manufacturing Practice (CGMP), from research and development to production and supply. Change management is a concept that ensures change is implemented in compliance with quality and regulatory requirements. It is the most critical element in a quality management system — inadequate change management creates a risk of non-compliance. Read more »