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.

What we can do for you

Within a few days our experienced risk management experts will help you to get your risk management file ISO 14971 compliant. We will

  • create a risk management plan, that is aligned to your "SOP risk management" (in case there is none, we will help, too),
  • evaluate your intended use (requirement of ISO 14971 chapter 4.2),
  • create a risk acceptance matrix,
  • perform a risk analysis (PHA, FTA, FMEA) specifically for your system and software,
  • assess possibilities and severities of harms and therefore the risks,
  • suggests measures for risk mitigation and risk control,
  • design a system for market surveillance and
  • make a concise, precise and documentation fully compliant with ISO 14971.

With this, you have everything you need to meet ISO 14971 and regulatory requirements in Europe and the USA (FDA). This risk management file will help you to fast get approval for your medical device by European authorities respectively the FDA.

How we will help you

We evaluate your current documents and products  and tell you exactly within two days what you have to do to have an ISO 14971 and FDA-compliant risk management file. We will help you for example

  • by answering your questions (via e-mail and phone). We even do that for free! (more information here)
  • by reviewing your documents and providing improvement suggestions (or directly implementing it)
  • with templates, which we exemplary and specifically create for your product and then you "only" need to fill in the blanks
  • by creating the complete risk management file for you

Interested? Here are your next steps:

Call us, write us an e-mail or fill out the contact form so that 

  • we understand your situation
  • we both can sign a confidential agreement (if required)
  • we create a customized quote just for you
  • we will support you with our full competency

You can reach us

What makes us different

  • compiled in a very short time:
    We are highly specialized on risk management for active medical devices and have
    • done it more than 100 times
    • a set of proven templates and
    • very risk management experts
    Therefore we are very fast what means for you no waste of time and faster sales.
  • at minimal cost:
    Not only that we work fast, but we also will empower you to to accomplish as you like as much work yourself. This immediately will minimize your cost and make you independent on consultants i.e. you will also save money also in a long run.
  • 100% ISO 14971-compliant:
    Risk management files are more often rejected than any other type of documents. Our experts are also auditors at notified bodies and know exactly, what is required. They make sure that you will avoid embarrassing complaints and time consuming, costly re-certifications and re-submissions. This enables you to pass approval without stress, delays and unnecessary costs.
  • designed to early identify and control risks for your patients and company: 
    Risk management file is more than an obligation. It helps you control possible risks for your patient that could be problems for your company in case of damage. With a professional risk management you will set the right priorities, design proper system architectures (instead of having to correct it later).
  • risk-free:
    Because we have done more than one hundred software documentations, we precisely can estimate efforts and costs. This gives you an absolute safety in your planning. In addition, we also give you a 100% satisfaction guarantee. You pay nothing if you are not completely satisfied.

Get in touch now, so we can plan together how you can get your risk management file at a minimal cost, in a very short time!

Contact Us