Tag: medical
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…
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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…
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Medical Device Single Audit Program (MDSAP): Segen oder Falle?
Das Medical Device Single Audit Program (MDSAP) wurde ins Leben gerufen, um einen Wunsch vieler Medizinproduktehersteller zu erfüllen: Statt vieler Audits und Inspektionen durch die Behörden verschiedener Länder soll es nur noch eines geben. Die Teilnahme am MDSAP soll ausreichen, um die Wirksamkeit und Konformität von QM-Systemen (z. B. Konformität mit ISO 13485 oder 21…
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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:…
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ISO 15223-1: Medical symbols and markings
ISO 15223-1 regulates the symbols that manufacturers can (or must) use to label medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of the relatively few standards under the MDR and added it to the list of harmonized standards. This alone makes it clear how relevant labeling has become. Read…
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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…
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Healthcare IT and medical technology jobs
We treat all inquiries relating to job offers and job applications with absolute confidentiality. You can communicate via us or directly with the specified contact persons. July 2024 Neuroloop Neuroloop, a subsidiary of Aesculap AG, is looking for a Senior Regulatory Affairs Manager for the Freiburg office. Bausch + Lomb | Perfect vision of Technolas…
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