General conditions of sale and use of Qualitiso templates


The Qualitiso templates bring a personalized information to the users, in order to accompany them for the regulatory and normative context relating to the medical devices.


The Qualitiso templates are intended for medical device manufacturers, experts and consultants as well as other organizations involved in the regulatory and normative context related to medical devices.

Scope of application

The Qualitiso templates consider the general regulatory context for medical devices in Europe.
Specific requirements are taken into account for Software Items and Electro-Medical Devices.


Qualitiso is committed to deliver contents meeting the claimed requirements.

Free support

The free assistance concerns the understanding and the implementation of the template system, it does not replace a training or a coaching.

The assistance is offered by email, telephone and videoconference.


Qualitiso is not responsible for the use made of the templates.

Printing and .doc extraction

The documents printed or extracted in .doc format are not releasable and are the property of the user.


The user has full access to Qualitiso templates until the subscription is terminated.

The User can share his access with his collaborators.
The user cannot share his access with his customers.

Automatic renewal of the subscription

After the end of the commitment period, the subscription is maintained at the initial price until termination.


The cancellation is free from one month to another, at the end of the commitment period.

Intellectual property

The templates are the intellectual property of Qualitiso, they can be used freely but cannot be copied, all or part, for other purposes than those planned by Qualitiso.