Risk management file: Get approval for your medical device in Europe and the US

We will help you compiling a 100% ISO-14971-compliant risk management file and developing safe products.

Risk management file: Get approval for your medical device in Europe and the US

We will help you compiling a 100% ISO-14971-compliant risk management file and developing safe products.

We support you in creating the most important technical documentation files in the audit so that you not only obtain fast approval and marketing of your medical device, but also reliably identify and avoid risks for your patients and your company. This gives you security - in every respect.

What we can do for you

Our risk management experts will work with you to 

  • create a risk management plan that is tailored to your "risk management procedure instruction" (if you do not have one, we will be happy to help)
  • review your intended purpose (requirement of ISO 14971 Chapter 4.2),
  • create the risk acceptance matrix,
  • conduct a hazard analysis (PHA, FTA),
  • identify further hazards based on your system and/or software architecture (FMEA),
  • assess the likelihood and severity of possible damage and thus the risks,
  • suggest risk minimization measures,
  • design a market surveillance system and
  • document all of this in a lean and precise manner.

This gives you everything you need to meet ISO 14971 and thus the regulatory requirements in Europe and the USA (FDA) and thus pass your audit and approval with 100% certainty.


What our clients say

"With the practical help of Professor Johner and his team, we were able to establish a 'viable' QM system for our company and successfully certify it under ISO 13485 in just a few months. We really appreciate the pleasant cooperation and the fact that we were able to complete the project in the planned time and on budget."

Dominik Blei, Head of Development, Society for Patient Support

"Over the past two days, we have had an initial ISO 13485 audit with the TÜV. The audit found no non-conformities and only gave a few comments for improvements.
The risk management and usability files, which the auditors described as exemplary, received particularly high praise. We will therefore receive our certificate in the near future.
I would like to take this opportunity to thank you all on behalf of the entire team. We found working with you to be a very productive, valuable experience.”

Raimund Oberhammer, World-Direct eBusiness solutions GmbH

How we can help you

We get an overview of any existing documents and your product and, within two days, tell you exactly what you need to do in order to document your risk management file in compliance with the requirements of ISO 14971 and the FDA in a short time. We will then support you, for example

  • with answers via email or telephone. We often do so free of charge (more information).
  • by reviewing your existing documents and providing suggestions for improvement (or implementing them directly),
  • with templates that we create as specific examples for your product and which you then "only" have to fill out in the same way,
  • by compiling the entire risk management file for you.

Find out how we can complete a project together.

Interested? Then do the following...

Give us a call, send us an email or fill out the contact form so we can 

  • understand your task, 
  • if required, agree a confidentiality agreement,
  • prepare a tailor-made offer and
  • support you as quickly, competently and cost-effectively as possible.

Why it makes sense to let us help you

With our support you will 

  • Document your risk management file in the shortest time possible: 
    It's our niche area, we have done it hundreds of times and can fall back on a whole plethora of templates. This will help you generate revenue more quickly and get going quickly with your product.
  • Produce it at minimum cost: 
    We not only work quickly, but also enable you to take on as much of the work as possible yourself. This minimizes your costs and keeps you independent of advisors - saving you money.
  • Create lean documentation in compliance with ISO 14971 and FDA requirements: 
    The risk management file is the file which causes the most objections. Our experienced experts ensure that you avoid embarrassing objections and time-consuming and costly reworking. This helps you get your approval without stress, delays and unnecessary costs.
  • Create documentation that averts risks to your company: 
    Risk management is more than an obligation. It helps you to control risks for your patients, which can become a problem for your company if they come to harm. With professional risk management, you will also set priorities correctly, design suitable system architectures (instead of having to improve them later) and thus develop more quickly and more economically.
  • Create documentation with no risk of any kind:
    Because we have already created large volumes of risk management files, we can estimate the work and costs accurately and agree them with you. This gives you total planning security. We also give you a 100% satisfaction guarantee. If you are not completely satisfied, you won't pay a dime.

Get in touch with us right away so that we can discuss the master plan that will help you obtain a compliant risk management file quickly and at low cost! You can contact us 


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