EUDAMED is the European database for medical devices. However, it is not only used to manage medical devices. The Medical Device Regulation (MDR) relies on EUDAMED and determines which requirements must be stored in this database. These regulations affect the work of manufacturers and also the work of authorities and notified bodies. 1. Which purpose…
DetailsThe QM manual is the top document in the document pyramid of the QM system. It is an entry point for employees and auditors to get a quick overview of the QM system. In this article, you will learn when you need a QM manual, its objectives, and what it should contain. 1. QM manual:…
DetailsIn a Standard Operating Procedure (SOP), companies define their processes, for example how they develop medical devices or provide services. Standards such as ISO 9001 and ISO 13485 require Standard Operating Procedures. Companies can define these specifications in their quality management manual directly or in independent documents. 1. Standard Operating Procedures: introduction, definitions a) Definition ISO…
DetailsThe Quality Management Representative (QMR) is also called the quality representative or “management representative” by ISO 13485. In this article, you will learn which tasks the person with this role is responsible for within an organization and which regulatory requirements must be observed. 1. Regulatory requirements a) Requirements of ISO 13485 The requirements of ISO…
DetailsA design change is a change in the design of a product. It is important to understand what regulatory implications arise from this and where there may be an impact on the validity of the product’s declaration of conformity. This article provides an overview and thus resolves many currently common misconceptions. 1. Design change: What it means…
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