Documentation

User Manual

DOCMAN will give you advice how to best write and create a user manual that is suited for your medical device and its intended users. It is recommended that the user manual is written in English and thereafter translated into desired languages. For translation services see Translation.

What are the requirements?

Creating a user manual for medical devices requires know-how about applicable standards, regulation and an understanding about health care staff and their needs. Additionally, the user manual must contain clear and understandable instructions in how to use and maintain a medical device in a simple way. The user manual must also include warnings and cautions, intended use and installation instructions. Quite often the amount of information can be overwhelming due to all requirements.

 

What about short form instructions?

A short form instruction is a good help if combined with a user manual. Users often want some kind of condensed information that they can store next to the medical device for quick help. A short form instruction can be used in the daily work for quick reference, but is not sufficient for introduction on a new medical device.

Start planning early

Medical Devices in Europe must be accompanied by a user manual and it is a good idea to start planning for your user manual when you are in the design phase. Parts of the technical file and other design documents contain information that shall be included in the user manual.

User focus

It is essential that the user feels secure about how the device functions, and especially in stressful situations. Clear instructions increases safety for the patient and lead to less frustration for health care personnel.
It is not simply true that a user manual must be complicated and difficult to understand!
 
Please contact DOCMAN for further information »