Protection Class in Accordance with IEC 60601-1
The protection classes in accordance with IEC 60601-1 specify the protective measures that manufacturers of medical electrical equipment must implement.
Medical Device Safety Representative – Responsibilities and Requirements
Medical Device Safety Representative: this role is required under the Medical Devices Act; however, since May 2021, this has only applied to manufacturers of in vitro diagnostic (IVD) devices, and no longer to manufacturers of medical devices.
Hospital Information Systems (HIS)
Hospital information systems (HIS) are a type of clinical information system. They are a central component of a hospital’s IT infrastructure. They help digitally manage and process administrative and medical patient data within a hospital. An HIS functions as an electronic patient record and manages processes ranging from admission, through diagnosis and treatment, to discharge…
DetailsAI Policy: What Really Belongs In It (And Why Data Protection Isn’t The Core Issue)
Artificial intelligence is becoming part of everyday working life – often faster than companies can react. An AI policy provides the framework for the secure, compliant and efficient use of AI systems. However, many AI policies fall short because they address the wrong problem. This article outlines the key components.
Decision Support Systems as medical devices
Decision Support Systems are also increasingly being used in medicine. If they are medical devices, they must meet the legal requirements (e.g., the general safety and performance requirements). The hype surrounding Artificial Intelligence, in particular Machine Learning, and users such as Watson are raising hopes for the performance of Decision Support Systems. This article presents…
DetailsProducts for general laboratory use: What manufacturers and laboratories need to know to avoid problems and unnecessary expense
One assumption persists: Products for general laboratory use such as PCR cyclers, NGS devices, fragment analyzers, centrifuges, pipetting robots, and extraction kits must bear a CE-IVD marking. Is this correct? There is often a lack of clarity about Hence, there are uncertainties, in order not to make themselves liable to prosecution. This article provides clarity…
DetailsLaboratory products for “Research Use Only” (RUO) – often a dangerous claim
Manufactures use the “Research Use Only” (RUO) label to declare that their products should not be used in diagnostic procedures. This enables them to avoid the time-consuming and costly documentation required for conformity-assessed in vitro diagnostic medical devices (CE-IVDs). Nevertheless, some medical laboratories still use RUO products in diagnostic procedures, sometimes even with the knowledge…
DetailsClass IIa medical devices: definition, examples, and requirements
Class IIa medical devices are among the most common products on the European market. This article explains which products fall into this class, which classification rules are relevant, and what regulatory consequences this has.
Sterilization of medical devices: A quick overview
Because the quality of medical device sterilization is crucial to the safety of these medical devices, the selection and validation of the sterilization process are regularly subject to audits and inspections. This article provides a quick overview of the various sterilization processes and regulatory requirements for medical devices and offers best practices for successfully passing…
DetailsRegulatory requirements for medical devices with machine learning
Manufacturers who use machine learning (ML) in their medical devices or IVDs must comply with numerous regulatory requirements. This article provides an overview of the most important regulations and best practices for implementation. It saves you the trouble of researching and reading hundreds of pages and helps you prepare perfectly for your next audit.
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