Future-oriented regulatory compliance through the digitalization of your technical documentation

Address the regulatory challenges in the approval process for your (IVD) medical devices with the Fit for Future Program

1. Constant changes on the part of legislators  
   The number, variety, and complexity of regulatory requirements are constantly growing. It is difficult to maintain an overview and avoid being overwhelmed.  
2. Highly complex devices and technologies  
   Today's customers expect not just single devices but comprehensive solutions. As a result, approval procedures are becoming increasingly complicated.  
3. Lengthy approval processes
   The approval of medical devices and IVD now takes a very long time, slowing down the mar-ket launch. Detailed knowledge of your own project progress and the success of the approv-al process is becoming increasingly valuable.  
4. Stress in the regulatory affairs department 
   Last-minute actions and late involvement cause stress and frustration in the regulatory affairs team.  
5. Unattractive jobs   
   Due to the high workload and lack of recognition, employee recruitment and retention suffer.
6. Competitiveness in an agile environment  
   Especially in a competitive market with an increasing number of new competitors, all of these problems affect a company's competitiveness.

Let's master the digital transformation of your regulatory affairs together

With the Fit for Future Program, the Johner Institute not only provides you with software but also comprehensive support to digitalize your regulatory affairs:

1. Structured guidance 
   Our tried-and-tested transformation roadmap is like a GPS for your company. In five quarterly sprints, it guides you to a clear target picture.
2. Individual accompaniment  
   Every week, we guide you step by step through the structured creation of a digital technical documentation, answer your questions, and ensure continuous progress. 
3. Practical blueprints
   We provide you with concrete templates, examples, and step-by-step instruc-tions. By automating repetitive tasks and guiding the compilation of the content of the technical documentation, you can significantly accelerate your approval processes. 
4. Regulatory review by top experts
   Our experienced experts carefully review the content for conformity with the MDR and IVDR and relevant standards to ensure compliance with regulatory requirements. We provide you with our findings and recommendations and give you customized tips for optimizing your technical documentation.

We pass our cost savings on to you directly

Digitalization projects can be very costly. We want to make digitalization possible for small and medium-sized companies, too.

How? The combination of our specialized software solution and our team's expertise guaran-tees maximum efficiency and regulatory safety on your way to market approval.

The Johner Institute is your partner for the digital future of regulatory affairs

We are not just an ordinary software provider. We provide (IVD) medical device manufacturers and notified bodies with comprehensive support from a single source. Because we do three im-portant things at the same time:

1. Compliant regulatory documents: We help you create your individual documents so that they ultimately comply with the legal requirements.   
2. Structure and efficiency: We guide you in creating your product-specific technical docu-mentation in a targeted and focused manner in digital form to make your company fit for the future.
3. Tailor-made software solutions: Our specially developed software solutions are tailored to your needs and help you master your regulatory challenges.

Our more than one hundred top experts, who participate in standards committees, audit notified bodies, and work with the FDA and European authorities on improving the regulatory system, contribute to your success.

Your satisfaction comes first – our guarantees

• Guarantee 1: Money-back guarantee
  If you are not satisfied with a quarter sprint, let us know by the end of the sprint, and we will refund your money. We want you to be absolutely happy! 
• Guarantee 2: Free exit after each sprint 
  If you have already achieved your objectives before the last sprint or no longer need to continue for other reasons, you can drop out after each quarterly sprint at no cost. Let us know four weeks in advance so that we can plan the next sprint accordingly.
• Guarantee 3: No vendor lock-in 
  We don't want you to be stuck in dependency. That's why you can export your data in a machine-readable format. 
• Guarantee 4: One-time price  
  It pays to be an early adopter! We offer you a one-time price for the digital capture of your technical documentation
• Guarantee 5: More regulatory safety  
  Our software inherently improves data quality, and our regulatory experts check the data. This inevitably leads to greater regulatory safety. It also eliminates a lot of tedious work, such as creating and formatting documents.