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.
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DetailsThe EU General Data Protection Regulation must be complied with starting at 25 May 2018, at the latest. Many companies, amongst them also medical device manufacturer and operators such as hospitals, are not adequately prepared. This article gives you a review of the main concepts and requirements of the General Data Protection Regulation and examines…
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DetailsMany people ask about the liability of individuals, management, and the company. After all, it is not only the Medical Devices Regulations that impose fines and imprisonment. The question of liability also arises for development service providers. Liability in Germany: Differentiating between criminal and civil law Civil law: Parties involved In civil law, the question…
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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.