This page is aimed at management, particularly executives at medical device and IVD manufacturers, notified bodies, authorities, and service providers responsible for regulatory and clinical affairs, quality management, and development.
The management tasks of these executives include, for example:
Information management
Collecting information from outside, keeping track of it, and taking the necessary measures. This includes information about
Quality management and strategy
Better positioning of your departments:
Resource management
Create the necessary preconditions:
Many managers rely on the support of the Johner Institute. It supports management with or takes over tasks from them.
Managers outsource regulatory activities and processes to the Johner Institute:
Manufacturers also outsource roles such as QM representative, EU representative, or PRRC.
Managers rely on the advice and opinion of the Johner Institute:
The views of the two board members of the Johner Institute are relevant for executives.
The Johner Institute supports medium-sized and large manufacturers in the digital transformation of regulatory processes and quality management.
Its enterprise software supports all regulatory processes, such as
As a manager, contact us right away. You will receive fast, discreet, and competent support.
With the eSTAR Program, the FDA aims to increase the efficiency of approval procedures (e.g., the 510(k) procedure) through digitalization. The Johner Institute is working with the FDA on the further development of eStar. This article tells you how forward-looking this approach is and whether you should or even must take part. 1. What is…
DetailsIn Article 120, the MDR establishes its transitional provisions, including the transition periods. However, the descriptions of these transitional provisions and transition periods are worded in a very complex manner. As a result, manufacturers are at risk of misunderstanding them and therefore not complying with regulatory requirements or incurring unnecessary costs. A flow chart in chapter 2 of this article…
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…
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…
Details“Remediation” is often synonymous with maximum stress: Notified bodies or authorities such as the FDA have discovered significant deviations that must be remedied with the highest priority and without regard to the workload of employees or budgets. This article will help you to complete such “remediation projects” in such a way that 1. Remediation: First…
DetailsIn December 2021, the EU extended the transitional periods of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) (Regulation 2022/112). In March 2023, the European Commission decided to abolish the “sell-off period” for IVDs that comply with Directive 98/79/EC (IVDD) (Regulation 2023/607). In January 2024, the European Commission published a proposal to amend the IVDR, which further extends…
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 EU regulations place high requirements on the so-called placing on the market of medical devices. Find out in this article what these regulations mean by placing on the market, what misunderstandings and contradictions you must be aware of, and what requirements manufacturers and devices must meet. 1. Placing on the market: Basics a) Definition…
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?…
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