Conquer your market with compliant and usable medical devices


What we can do for you

Usability makes the difference:

  • With compliant usability files you quickly and safely get market approval
  • With usable medical devices you achieve market success

We help you to...

  • compile FDA and IEC 62366 compliant usability files (read more)
  • derive the real user requirements and design user interfaces (read more)
  • evaluate the usability or your medical product with formative and summative usability tests (read more)
  • recruite participants for usability studies (read more)

Focus #1: FDA/IEC 62366 compliant usability files

Human factors engineering file

We help you to get market approval by creating usability files that comply with medical device regulations.

What we can do for you

We examine your situation and tell you exactly within two days what you have to do to document your medical device compliant with IEC 62366-1:2015 and FDA HFE requirements. We will help you for example

  • by creating/compiling the complete usability file for you
  • 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

Which documents you need to submit

Our team of experienced usability experts (such as ISO 9241 editors, members of IEC 62366 standard committee, auditors) will help you within a few days to create IEC 62366 and FDA standards-compliant usability file including

  1. development plan or development SOP (adding "usability aspects")
  2. use specification,
  3. specification of use scenarios,
  4. listing of main operating functions,
  5. usability verification (e.g. by inspection),
  6. formative and summative usability testing with validation plan and validation report
  7. update of your risk management file (use related risks and risk control measures)

With this, you have everything you need to 100% pass your audit and get EU and US market approval.

Contact us now to create a usability file that will make you shine in audit.

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Focus #2: User interface design

We help you to get market success by ensuring the usability of your medical devices.

What we can do for you

With systematic requirements engineering, we will help you

  • discover the real user needs and user requirements. This will be your company's treasure. Be aware: If your ask your users for requirements you won't get user requirements but user requests.
  • identify the core tasks in the given context of use which is the basis for systematic product innovation.
  • specify the user interface, that makes every manual unnecessary, minimizes risks and something that your customers will love.

With this, you have everything you need to make your product become a "game changer" in your market.

How we will help you

  • We do contextual interviews and identify user needs, user requirements, core tasks and document these for your product management, 
  • derive usage scenarios,
  • design user interfaces,

Contact us now. This will be your first step to developing medical products that will revolutionize your market.

Contact us now

Focus #3: Usability testing

Both FDA and IEC 62366 require a formative and summative usability such as usability testing.

What we can do for you

Our human factors, usability and regulatory affairs experts help you to

  • inspect the user interfaces of your medical device against standards (e.g. ISO 9241) and your usability specification i.e. they perform a usability verification
  • write usability validation plans (specify number of participants, define pass-fail criteria, 
  • select the use scenarios to be evaluated based on risks etc.)
  • recruit participants for usability tests in the US and EU
  • perform usability tests 
  • rent usability testing facilities 
  • write usability test reports

Contact us now to create a usability file that will make you shine in audit.

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Why usability/human factors engineering is so important

How you benefit from usability engieering

Applying a state of the art usability / human factors engineering will help you to

  • sell your product faster
    Our usability and regulatory affairs experts are auditors and members of standard committees as IEC 62366. They have compiled usability files more than 100 times and help you to compile a usability file 100% compliant with US and European regulations. Thereby you will avoid problems in audits, you will get market approval and generate sales faster.

  • minimize your costs
    We will minimize your costs, as we are experience and working fast and as we focus on what is really important for ensuring compliance and the usability of your products. Because of this as well, we can precisely estimate the workload and cost and make a good deal for you. This gives you absolute security in your planning. For that, we give you 100% satisfaction guarantee. You pay nothing, if you're not absolutely satisfied.

  • accelerate your development and achieve market success
    Developing products without systematic usability and requirements engineering will lead to unsatisfied users requesting changes to your product. This re-work is costly. We will show you how to systematically derive stakeholder, user and system requirements.

  • eliminate risks:
    Because we have done more than one hundred risk management files, 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.
    And there is even a bigger risk you have to avoid: The risk for patients due to usability problems. We help you avoiding all these risks!

Why you should avoid an insufficient usability engineering

Unfortunately, we frequently observe the following problems:

  • Delay of market approval and even market bans
    Notified bodies are obligated to examine your usability file. If the file does not comply with regulations such as IEC 62304 or the FDA HFE guidance, you have to revise it. That costs you a lot of money: for auditors, for file revision and for profit loss due to delay of market release. This kind of feedback by authorities is also embarrassing and frustrating.

  • Lack of market success 
    Many manufacturers ignore that products with usability problems lead to unsatisfied customers, unnecessary high costs for support and constant rework (then called "development" or "improvement"). The consequences are frustrated teams, because there is no more time for real innovation. It leads to finger pointing between product management and development. Eventually customers will always chose products with the best "user experience".

  • Harm to patients, damages
    Too many companies recognize usability problems only when something bad happens, such as when a patient is injured. But then it is too late: It causes compensation claims and damage to the company's image. these problems are no exception: 70% of FDA recalls of software products are due to usability problems!

Make sure this doesn't happen to you and contact us now, so we can discuss the master plan to create a usability file for your products that will enable you to pass audits and get market approval fast and successfully.


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

Contact us now