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Quality Declaration

In practice:
- New MA legislation
- Substantial changes
- MA Renewal


“An essential question related to medical products lies in
the way the information about health risks is passed on to the users”


The users of the medical system and their relatives expect quality in the information they receive when taking medication. To give special attention to the leaflet provided with a medical product will satisfy this demand of good quality.

The patients know that they will get accurate and reliable information from this leaflet. That’s why the Patient Information Leaflet is the third source of information that the patient receives concerning his treatment, and studies have shown that it even improves the observance. It is therefore absolutely indispensable that the Patient Information Leaflet is as clear and legible as possible.

In practice, the necessary information is difficult to obtain for the patients and it is often not correctly adapted or it is unclear, with regard to the content as well as the form.

This is where the role of the readability test becomes important.

Analysis has shown that, during a readability test an average of around 98% of the questions was understood (after revision of the leaflet). For comparison, when testing leaflets without doing any pre-editing or testing, scores have been significantly lower, around 70%. In this way, to use readability testing is decreasing the risks related to the use of medication.

Founder of DPMI

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