Document control is a documented procedure that specifies how documents are created, reviewed, approved, labeled, distributed, and updated. Organizations certified according to ISO 9001 or ISO 13485 are obliged to document control. 1. Subject matter of document control It is obvious that document control is about documents. What is less obvious is what documents are.…
DetailsPDMS 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)…
DetailsCompanies 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…
DetailsThis 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…
DetailsMedical device manufacturers are obliged to systematically collect and evaluate clinical data, both before and after the approval of their products. The EU Medical Device Regulation (MDR) has increased the requirements for the scope and quality of the required clinical data. This article provides you with an overview of the regulatory requirements and gives tips…
DetailsWhat 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…
DetailsThe 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…
DetailsThe 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…
DetailsRegulatory affairs managers take care of the approval of medical devices. In this article, you will learn, Update: Impact of the digital transformation on the tasks of regulatory affairs managers added! 1. Responsibilities of regulatory affairs managers Regulatory affairs managers are responsible for ensuring that 2. Tasks of regulatory affairs managers To achieve these objectives,…
DetailsLaws 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…
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