The ISO 13485:2016 is an international regulatory standard that specifies the requirements for Quality Management Systems (QMS) in the medical device industry. A QMS that meets the ISO 13485:2016 requirements demonstrates a commitment to quality and customer...
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...
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...
Like in any software implementation project, there are many steps necessary to ensure that the eQMS implementation, training, and deployment are a success. In this article, we will briefly discuss why a life science organization would typically consider implementing...
It is easy to get confused by the difference between Quality Assurance (QA) and Quality Control (QC). Some use the terms interchangeably, although there is a notable difference between the two. No time to read? Listen to this article:...
![ISO 13485:2016 Compliant QMS [Role of an eQMS]](https://simplerqms.com/wp-content/uploads/2022/10/integrated-iso-13485-qms-illustration.svg)
![21 CFR Part 820 Quality System Regulation [Role of an eQMS]](https://simplerqms.com/wp-content/uploads/2022/11/fda-21-cfr-part-820-quality-system.svg)
![EU MDR Quality Management System [Role of an eQMS]](https://simplerqms.com/wp-content/uploads/2022/11/eu-mdr-qms-icon.svg){kind=icon}
![eQMS Implementation Process [Checklist]](https://simplerqms.com/wp-content/uploads/2019/10/eqms-implementation-400x250-1.svg)
