Inhaber der Johner Institut GmbH
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…
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 DAkkS, the German Accreditation Body, is Germany’s national accreditation authority. Recently, manufacturers, associations, and certification bodies have been raising their voices against the DAkkS. It is being vilified as an example of how German bureaucracy nips any innovation in the bud. What is the truth of these accusations? Are they justified? This article presents…
DetailsThe EU Data Act came into force in December 2023. It aims to create a new legal framework for handling data that will not only affect US tech giants. The EU Data Act will have an impact on many companies that process data, including medical device manufacturers. This article will help you assess: 1. EU…
DetailsThis FAQ provides answers to the most common questions that companies such as medical device manufacturers have about quality management systems (QM systems) and ISO 13485. Question 1: Who needs a QM system? The EU Medical Device Regulations (MDR and IVDR) as well as the FDA set requirements for QM systems. These requirements are relevant…
DetailsPhantoms in medical technology help to develop, validate, “approve” and monitor medical devices in the markets faster and more effectively. This article describes which organizations particularly benefit from the use of these phantoms and what requirements they must meet. 1. Examples of phantoms in medical technology Anthropomorphic phantoms are replicas of bodies that behave like…
DetailsLegislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR) and EU Regulation 2017/746 (IVDR). This then raises the question of how to deal with legacy devices. These are the medical devices that manufacturers have legally placed on the market under the old directives…
DetailsThe digitalization of the production is an essential part of the digital transformation of manufacturing companies. However, not all companies benefit to the same extent from digitalization. This article describes, 1. What is the digitalization of the production? The digitalization of the production covers two areas: 2. Why is the digitalization of the production important?…
DetailsMDCG published guideline MDCG 2023-4 in October 2023 entitled “Medical Device Software (MDSW) – Hardware combinations – Guidance on MDSW intended to work in combination with hardware or hardware components.” Criticism 1: Unclear scope of MDCG 2023-4 The title gives the impression that (all) types of combinations of hardware and Medical Device Software (MDSW) are…
DetailsMedical device manufacturers have high expectations of Regulatory Information Management Systems (RIMS). The costs and efforts involved are immense and usually much higher than expected. The benefits, on the other hand, are not clear. This article will give you some hints, 1. Definition: RIMS 2. Goals of RIMS Pharmaceutical and medical device manufacturers expect several…
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