Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed an innovative and award-winning, extended vision foldable, presbyopia-mitigating, intraocular lens (IOL) for use by patients undergoing cataract surgery. This device will...
The tough part for the medical device industry is that this landscape of regulations is constantly changing, and therefore, intimidating. The European Union’s Medical Device Regulations (EU MDR) which came into effect on 26 May 2021 after a three-year transition...
ISO 13485 is an internationally recognized Quality Management System (QMS) standard for the medical device industry. Meeting the requirements of ISO 13485 Quality Management System (QMS) demonstrates a commitment to quality and customer satisfaction, which is...
Electronic Quality Management System (eQMS) Definition An Electronic Quality Management System, or eQMS, for short, is a new digitalized approach to a Quality Management System (QMS). An eQMS is software that helps manage and document business processes for product...
When a life-sciences organization has an effective quality management system (QMS) in place, it is demonstrating to its end-users and the regulatory agencies that its products/services are of the highest industry standards. Similarly, when the sponsor of a clinical...
In any industry, and particularly so in the life sciences industry, the basis of an organization’s efficient Quality Management System (QMS) is proper documentation. As a life science organization, you will understand the importance of quality at all levels. Quality,...
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