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.
Important tasks of management
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
- regulatory changes,
- market trends (technologies, competitors, customers) and
- the company’s own devices (post-market surveillance)
Quality management and strategy
Better positioning of your departments:
- Initiating strategic projects (e.g., digitalization, outsourcing, restructuring)
- Defining regulatory strategies
- Contributing to the improvement of the QM system (e.g., during management reviews)
Resource management
Create the necessary preconditions:
- Selecting service providers and negotiating contracts
- Creating, securing, and monitoring budgets for the departments
- Ensuring the size and competence of teams of experts
Support for management
Many managers rely on the support of the Johner Institute. It supports management with or takes over tasks from them.
a) Outsourcing
Managers outsource regulatory activities and processes to the Johner Institute:
Manufacturers also outsource roles such as QM representative, EU representative, or PRRC.
b) Consulting
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.
c) Software & digital transformation
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 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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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…
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The 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…
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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…
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In 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…
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In 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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On September 14, 2024, the new version of the German Health Interoperability Governance Regulation (or IOP Governance Regulation, or GIGV for short) came into force. The German Ministry of Health published a draft bill (only available in German) containing the recitals on April 24 of that year. This version of the GIGV will replace the…
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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…
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Regulatory 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,…
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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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