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.
“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…
DetailsMore and more medical devices are using artificial intelligence to diagnose patients more precisely and to treat them more effectively. Although a lot of devices have already been approved (e.g., by the FDA), a lot of regulatory questions remain unanswered. With the AI Act, the EU has published a regulatory framework for AI, and not…
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?…
DetailsDefining the regulatory strategy is one of the central tasks of the regulatory affairs departments at medical device manufacturers. Why is a good regulatory strategy so important? What do regulatory affairs experts need to do? This article provides the answers. 1. What does a regulatory strategy determine? a) Background Manufacturers of medical devices must comply…
DetailsThe Quality Management Representative (QMR) is also called the quality representative or “management representative” by ISO 13485. In this article, you will learn which tasks the person with this role is responsible for within an organization and which regulatory requirements must be observed. 1. Regulatory requirements a) Requirements of ISO 13485 The requirements of ISO…
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…
DetailsWith PFAS, the EU plans to ban an entire class of chemicals. In doing so, it is not only threatening the supply of medical devices but also the competitiveness of EU manufacturers. After all, the assumption that manufacturers inside and outside the EU are treated equally is just one of the EU’s five misconceptions in…
DetailsMany companies consider Regulatory Intelligence so important that they create their own roles and departments for it. This article clarifies what Regulatory Intelligence is, how companies can benefit from it, and where tools can provide support. 1. What is “Regulatory Intelligence”? This includes gathering and analyzing regulatory information from various sources, including regulatory agencies, industry…
Details
Privacy Preference
We need your consent before you can continue on our website. If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. You can revoke or adjust your selection at any time under Settings.
Privacy Preference
If you are under 16 and wish to give consent to optional services, you must ask your legal guardians for permission. We use cookies and other technologies on our website. Some of them are essential, while others help us to improve this website and your experience. Personal data may be processed (e.g. IP addresses), for example for personalized ads and content or ad and content measurement. You can find more information about the use of your data in our privacy policy. Here you will find an overview of all cookies used. You can give your consent to whole categories or display further information and select certain cookies.