IEC 60601-compliant documentation:
Electrical safety, EMC, basic safety

We ensure that you develop your product quickly and in compliance with the requirements of the IEC 60601 family and pass the safety tests without having to familiarize yourself with all the regulations. So that your product is quickly on the market.

What we can do for you

Before you are allowed to sell your product, you must prove its safety, including electrical safety and electromagnetic compatibility. We can help you with this:

  • Create architectural concepts that meet the principles of functional and integrated safety
  • Develop and evaluate (protective) measures for electrical safety 
  • Conduct reviews of the system architecture of your ME devices and ME systems (according to the "IEC 60601 Architecture Assessment Framework")
  • Analyze risks compliant with the requirements of IEC 60601-1 (also A1:2012)
  • Create an EMC test plan 
  • Identify key performance characteristics and define measures
  • Support you in the selection of the test laboratory (EMC, electrical safety) and testing
  • Create the technical documentation or review an existing one

This will provide you with all the documentation you need for your technical documentation, thus for your declaration of conformity ultimately for placing your product on the market.

 

 

 

Why it makes sense to let us help you

With our assistance, you will be able to improve the documentation of your software development 

  • in the shortest possible time: 
    We specialize in this, have done it well over 100 times and have an arsenal of templates to fall back on. So you can generate sales faster with your product and not waste time.
  • Create at lowest cost: 
    Not only do we work quickly, but we empower you to be able to do as much of the work yourself as possible. This minimizes your costs and makes you permanently independent of consultants - so you save money.
  • Create lean and IEC 60601-compliant (3rd edition, 4th edition): 
    Our experts are not only auditors, but also members of standards committees and know exactly what matters. They ensure that you avoid awkward complaints and time-consuming and costly rework, and thus you get your approval without stress, delays and unnecessary costs.
  • design to accelerate your development: 
    We are engineers who have years of experience as system architects and developers -- in other words, real practitioners. This will also help you turn your ideas into revenue-generating products faster.
  • Achieve without any risk:
    Because we have already created well over a hundred product files, we can precisely estimate the effort and costs and agree with you. This provides you with absolute planning security. In addition, we give you a 100% satisfaction guarantee. You pay nothing if you are not absolutely satisfied.

 

Interested? Then do the following now...

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

  • understand your product,
  • exchange a non-disclosure agreement if necessary
  • provide a customized quote, and
  • Assist you in writing your clinical evaluation as quickly, competently and cost-effectively as possible.
     

You can reach us: