CE-marking and further development of safe, comfortable and reusable incontinence protection

Purpose and goal:

Comfydence develops, sells and markets absorbent panties that replace disposable protection during menstruation, discharge & sweat. The panties are also suitable for urinary incontinence, but cannot be marketed for this without CE marking for medical devices. The objective of the project is to ensure that the company has the competence and the processes required for a CE marking, as well as to develop and manage products in the medical technology area.

Expected results and effects:

CE-marking of the Comfydence range would help to reduce stigma, the limitations of quality of life and psychological health that come from incontinence. Women who suffer from incontinence get access to a reusable, safe and comfortable aid. This gives the company a great competitive advantage over other actors, the opportunity to market in more areas of use, reduce the amount of waste from incontinence protection & increase the opportunities to sell the goods via care and new channels abroad.

Approach and implementation:

In order to CE mark the range, the company needs support in risk management, set up technical documentation for the products and implement a quality management system. RegSmart, which is an experienced and competent partner in the certification of medical devices, will support Comfydence in increasing the level of internal competence in medical technology and in developing, implementing and maintaining the routines and processes required for medical devices.