PDMS (Patient Data Management System): What you should consider from a regulatory perspective

Healthcare & Health IT, Regulatory Affairs, Software & IEC 62304Leave a comment

PDMS stands for patient data management system. These clinical information systems are typically used in hospitals, especially in departments that treat patients in intensive care. PMDS are experiencing a new boom in Germany as a result of the funding provided by the Hospital Future Act (Krankenhaus-Zukunftsgesetz, KHZG). This article provides 1. PMDS: Functionalities and requirements Patient data management systems (PDMS)…

Details

7 tips for the successful digital transformation of medical device manufacturers

Healthcare & Health IT, Regulatory AffairsLeave a comment

Companies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…

Details

Clinical evaluation: you can easily avoid these misconceptions and mistakes

Regulatory AffairsLeave a comment

This article outlines the five most common misconceptions and mistakes medical device manufacturers should avoid during clinical evaluation and how to avoid them. The five most common misconceptions Misconception 1: A class I device does not require a clinical evaluation This is wrong. All medical devices must meet the essential requirements of the MDR (formerly…

Details

Verification and validation: Differences and definitions

Software & IEC 62304, Systems Engineering for Medical Devices, Usability & IEC 62366-1Leave a comment

What is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article 1. Verification a) Definition This definition does not explain what type of “requirements” need to be confirmed by verification. Limiting these requirements to product or component requirements is recommended to avoid…

Details

Summative evaluation: The following points are essential

Usability & IEC 62366-1Leave a comment

The term summative evaluation can be translated as “final evaluation.” A summative evaluation checks at the end of the development phase whether users can operate a device or a user interface safely. This article provides an overview of the regulatory requirements for the “summative evaluation” (sometimes also referred to as “summative assessment“) and gives you…

Details

ISO 10993-17: What the standard has changed and now requires from manufacturers

Systems Engineering for Medical DevicesLeave a comment

The ISO 10993-17 standard is part of the ISO 10993 series of standards on biocompatibility. ISO 10993-17 describes the procedures for Toxicological Risk Assessment. In the fall of 2023, a comprehensive standard revision was published after over 20 years. Medical device manufacturers should know, This article will help. 1. Context of ISO 10993-17 1.1 The…

Details

Risk management in hospitals and at other operators

Healthcare & Health IT, Risk Management & ISO 14971Leave a comment

Laws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. This article presents the most important regulatory requirements and provides tips for implementation. 1. Typical risks in a hospital a) Risks for patients The most important risks for patients include: b) Risks for all people in…

Details

Qualification and classification of IVD software

Regulatory Affairs, Software & IEC 62304Leave a comment

The qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and what costs arise for “approval.” This article will help you correctly qualify and classify IVD software, thereby avoiding regulatory problems and the resulting costs and delays. 1. Definition of terms 1.1 Qualification Qualification is…

Details