Product re-qualification

  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.

  Benefits:

• 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)
• composition.