TIR 45: Agile software development for medical devices

The TIR45 (“Guidance on the use of AGILE practices in the development of medical device software”) is a Technical Information Report (hence TIR) of AAMI, the Association for the Advancement of Medical Instrumentation. First published in 2012, TIR45 has one primary objective: To guide medical device manufacturers on developing software compliant with FDA requirements while…

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PMS trend analysis – a complex issue where you cannot fail

Trend analysis is a legal obligation of all medical device manufacturers, especially in “Post-Market Surveillance.” Manufacturers must not fail in the selection and application of suitable statistical methods for trend analysis. This is because the focus of authorities and notified bodies is increasingly shifting to monitoring post-market activities. This article provides a quick introduction to this…

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Medical device software PC: Software manufacturers, watch out!

The term “medical device PC” is not clearly defined. However, most people understand a medical device PC to be Depending on the constellation, manufacturers must fulfill different regulatory requirements. These are presented in this article. 1. Case distinctions for medical device PCs Case A: Standalone software is delivered If you as a manufacturer only supply…

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Medical device certification: Does it exist?

Medical device certification, MDR certification, CE certification. These are terms that are used frequently. But is there even such a thing as medical device certification? This article answers the question. 1. Summary The short answer is: There is no formal medical device certification, CE certification, or MDR certification. However, manufacturers do require certifications or certificates.…

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Switzerland: What (IVD) medical device manufacturers should be aware of

Switzerland is important both as a manufacturing location and as a market for medical device manufacturers who are based outside Switzerland. However, since May 26, 2021 (for medical devices) and May 26, 2022 (for in vitro diagnostic devices | IVD medical devices), manufacturers from Switzerland as well as manufacturers from other markets (e.g., the EU)…

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Medical device approval: Approval procedures in the EU and the USA

People often talk about the approval of medical devices, even if something else is meant – sometimes a certificate of conformity, sometimes a “clearance,” sometimes a successfully completed conformity assessment procedure. Terms like “MDR approval” are even misleading. This article clarifies what a medical device approval means and when manufacturers need one in the first…

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Supplier evaluation – supplier selection – supplier audits

The MDR and IVDR, as well as ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, supplier selection, and supplier monitoring. This article not only gives you an overview of the regulatory requirements. It also gives you tips on how to implement them and tells you when a supplier audit is necessary. 1. Basics of supplier management a) Examples…

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Risk mitigation through information?

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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