Christian Rosenzweig, Author at Medical Grade Software Expertise

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

By Christian Rosenzweig April 30, 2024 Leave 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)…

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Risk management in hospitals and at other operators

By Christian Rosenzweig March 26, 2024 Leave 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…

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The FDA’s cybersecurity guidance documents

By Christian Rosenzweig March 26, 2024 Leave a comment

Medical device cybersecurity is a focus not only for the FDA but also for other legislators and authorities, both in the US and other markets. This is understandable The USA has added requirements for cyber devices to the Food, Drug & Cosmetic Act (FD&C), and the FDA has published several guidance documents on cybersecurity, which…

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Let service providers take care of risk management?

By Christian Rosenzweig January 30, 2024 Leave a comment

Outsourcing risk management to service providers. Wouldn’t that be convenient? But is that allowed? And how much sense does it make anyway? Conversely, what should you as a service provider not be burdened with under any circumstances? This article provides the answers. It suggests how manufacturers and service providers can divide their activities and gives…

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SBOM: Software Bill of Materials

By Christian Rosenzweig January 23, 2024 Leave a comment

Laws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always sufficient to meet these requirements. In particular, medical device manufacturers who do not supply and use SBOMs for their software are no longer accepted in the market. Here are the reasons. 1.…

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IT security for legacy devices

By Christian Rosenzweig November 28, 2023 Leave a comment

Understandably, laws and standards also require IT security for legacy devices. However, the way in which these requirements are formulated often leads to confusion. For example, legislators and standard committees have been unable to agree on common definitions. One definition refers to the IT security of legacy devices, another to the IT security of old…

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Risk management plan: The most important advantages

By Christian Rosenzweig November 7, 2023 Leave a comment

The risk management plan is one of the most important documents in technical documentation. Accordingly, authorities and notified bodies examine this plan intensively. However, it is not only from a regulatory perspective that medical device manufacturers benefit from a precise risk management plan. This article 1. What a risk management plan is In a risk…

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DIN EN IEC 80001-1:2023

By Christian Rosenzweig June 6, 2023 Leave a comment

IEC 80001-1 has the long title “Application of risk management for IT-networks containing medical devices – Part 1: Tasks, responsibilities and activities“. This article reveals what the standard requires and why manufacturers should also consider it. 1. About DIN EN IEC 80001-1 a) Objectives of DIN EN IEC 80001-1 The standard aims to help minimize…

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Risk mitigation through information?

By Christian Rosenzweig May 23, 2023 Leave a comment

Whether risk mitigation through information is permitted regularly leads to discussions. The answer to this question is important because it determines the conformity and non-conformity of medical devices. This article provides the answer and thus resolves a “historical misunderstanding.” 1. Regulatory framework All manufacturers are obliged to minimize the risks posed by their medical devices.…

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The 7 most common risk management errors

By Christian Rosenzweig May 2, 2023 Leave a comment

This article identifies the seven most common risk management errors that Johner Institute and its auditors encounter most often. It also offers advice on how to avoid these errors. Risk management is among the most important requirements medical device manufacturers must meet. Therefore, it is important that they avoid risk management errors. 1st error class:…

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