Tag: devices

QM certification for producers of medical devices

Under QM certification If one refers to the certification of a quality management system (QM or QMS system) by a certification office. The certification confirms the certified company that its QM system is sufficient for a standard, generally a standard (for example ISO 9001, ISO 13485) or a law (for example MDR, IVDR). 1. Who…

CMR substances and medical devices: to meet the legal requirements

The use of CMR fabrics is rigorously regulated. The MDR also regulates the CMR fabrics and places rigorous requirements for producers of medical devices. This article helps to meet these requirements. 1. CMR fabrics: the challenges Cmr stands for: CAncerogeno (cancer, cancer) MUtagen (genetic modification) RAnd -Oxic Productor (reproductive stoxical) CMR fabrics are demanding for…

Tipps Zum FDA Guide “Interoperable medical devices”

Die FDA The importance of medical devices’ abuse recognized at the beginning and 2017 Dokument Guida ‚Interoperable medical devices’ Published. The American authority would like to take into account the fact that the interoperability of medical devices is important for health care on the one hand. On the other hand, problems with a lack of…

Configuration management for medical devices

Configuration management is much more than just using version management tools like git or svn. This becomes immediately clear if you look at the IEC 62304 and FDA guidance documents. Read this article 1. Configuration management, basics a) What does configuration management include Configuration management goes beyond version management. It is based on four pillars:…

Was Hersteller über Legacy Devices wissen müssen

Gesetzgeber ändern kontinuierlich die Regelwerke für Medizinprodukte. So ist das in Europa mit den EU-Verordnungen 2017/745 (MDR) und 2017/746 (IVDR) geschehen. Dadurch kommen Fragen zum Umgang mit Legacy Devices auf. Das sind Medizinprodukte, die Hersteller nach den alten Regelungen legal auf den Markt gebracht haben und weiterhin bringen, die aber gegebenenfalls die neuen Regelungen nicht…

Electronic instructions for the use of medical devices

EU Regulation 2017/745 (MDR) specifies the general requirements for instructions for use (IFU for short). The Implementing Regulation (EU) 2021/2226 regulates whether it can also be available in electronic format (eIFU). We have summarized the requirements of the electronic operating instructions for you. 1. Requirements for using the electronic operating instructions According to Implementing Regulation…