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