The Johner Institute supports medical device manufacturers, their suppliers, notified bodies, and authorities in all projects in a regulatory context. This includes transformation projects.
Projects either serve to run the business or change the business. The latter projects are transformation projects. Projects for the digital transformation of a company are particularly important transformation projects. The Johner Institute supports medical device manufacturers, their suppliers, notified bodies, and authorities in all projects in a regulatory context. This includes transformation projects.
Some of the projects serve to “change the business”. This also includes digital transformation projects.
Digital transformation is an ongoing process, as technologies and customer needs constantly evolve. Digital transformation projects have the following objectives:
While the process is ongoing, the projects are time-limited. They aim to achieve concrete outputs that contribute to the above objectives. Examples of these outputs are:
This article on digital transformation provides an overview of what organizations need to pay attention to.
Read here how to make digital transformation a success in your company.
The other transformation projects must also serve the company’s objectives, in particular to:
Typical outputs of these projects are
You will find the most essential starting points for transforming regulatory processes and organizations in the articles linked below.
Do you have questions about the transformation of your company? You can get answers in our free micro-consulting.
Would you like to learn more about how your company can benefit from a transformation and what concrete steps you can take to make it a success? Contact us; we will be happy to support your transformation.
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…
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?…
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…
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…
DetailsThe digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes 1. Drivers of the digital transformation of notified bodies The period in which notified bodies, as an oligopoly, were allowed to pick and choose customers and determine prices and conditions is coming to an end.…
DetailsRegulators still publish laws and regulations as texts. Just as it has been for thousands of years. Regulation as Code represents a radical paradigm shift away from this practice. Is it possible to transform laws into algorithms? Why should anyone want to do this? How should you get ready for this as a regulator, manufacturer, authority, or…
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