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.
The EU AI Act has been published. Many manufacturers of medical devices and IVD, as well as other healthcare players, are faced with the major task of understanding the 140+ pages of legal text and complying with the requirements. Note: Infringements/violations of the AI Act are punishable by a fine of up to 7% of…
DetailsRegulation (EU) 2025/327 on the European Health Data Space (EHDS for short) is another European regulation that may affect medical device and IVD manufacturers. This article explains what this regulation requires and what these manufacturers have to do by when, as well as the possible advantages of the EHDS and the EHDS Regulation.
DetailsA lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required for these authorizations. The five steps presented in this article will help manufacturers to manage these risks better. And this is…
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
DetailsMore and more medical devices are using artificial intelligence e.g., to diagnose patients more precisely and to treat them more effectively.
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.
DetailsThe Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities from different countries with one audit. Participating in the MDSAP shall suffice for verifying effectiveness and conformity of QM systems (e.g., with ISO 13485 or 21 CFR part 820). In…
DetailsWith 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.
DetailsIn Article 120-123, 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…
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…
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