Tag: “ISO 13485”

When implementing a Quality Management System (QMS) for your medical device manufacturing organization, you will find that one of the first things you need to write according to ISO 13485:2016 is your Quality Policy. So,...

In the ISO 13485:2016 Quality Management System (QMS), management of suppliers is a critical part of the success of the purchasing process. So, what do you need to do for supplier management, and how can...

ISO 13485:2016 is an international quality management standard for manufacturers of medical devices. It specifies the requirements for a quality system in which the manufacturer needs to demonstrate its ability to deliver safe medical devices....

Regulatory requirements for medical devices are becoming tighter every year. Manufacturers are expected to prove that their quality management processes are under control to ensure best practice in everything they do, while observing an increasing...

The Medical Device Directive (MDD) was first published in 1993. Since then, it has remained unchanged, although different European standards and guidance (particularly MEDDEV) have been continuously updated during this almost 30 years. Very often,...

According to the definitions in the European Union’s Medical Device Regulation (MDR) (Article 2), “label” means any written, printed, or graphic information appearing either on the device itself, or on the packaging of each unit...