MDR certification of a height adjustable hygiene toilet

Purpose and goal

The project´s aim is to obtain competence enhancement within the Medical device directive, MDR. This in turn should lead to an MDR certification of one of our products.

Expected effects and result

Expected effects of the project are for the organization to obtain increased knowledge in the area and certification of the product.

Planned approach and implementation

Planned arrangement with assigned consultant: Part 1 - Regulatory analysis - work related to qualification, classification and plan for activities. Part 2 - Applicable eligibility requirements - a more in-depth analysis where the necessary basis is drawn up to start implementation/creation of the required technical documentation Part 3 - Operational support - knowledge transfer and training of our organization in how to make different types of documentation and work within the framework of the applicable requirements