Objective: Re-qualification of the product (eg. cosmetic) into the medical device.
For whom: For companies wishing to carry out the change of the intended use of a product.. This applies in particular to the borderline devices or those in which a small modification of the scope of the intended use or the composition allows to qualify the product as a medical device (eg. cosmetics, shoes, bathroom accessories, mattresses, textiles etc.).
The range of consulting services:
- verification / evaluation of products belonging to the group of medical devices;
- defining the conditions and requirements to be met by the product according to the requirements for medical devices,
- classification of a medical device to the appropriate class - defining boundary conditions.
- cost estimation of the product re-qualification, including additional research and / or clinical evaluation.
- preparing the documentation of the medical device (instructions for use, labels)
- certification (if applicable) and the registration of a medical device in the Office for Registration of Medicinal Products, Medical Devices and Biocides.
- wider range of customers,
- lower price by reducing the VAT rate from 23% to 8%,
- opening of new distribution channels (pharmacies),
- building the confidence in the brand of the product as a medical device.
The time to deliver the service depends on the complexity of the product:
- type (eg. mechanical, electrical, etc.)
- class (I, IIa, IIb .III)