MDR certification of a height adjustable hygiene toilet
Reference number | |
Coordinator | MDV Välfärdsteknik AB |
Funding from Vinnova | SEK 200 000 |
Project duration | July 2023 - September 2024 |
Status | Ongoing |
Venture | Medtech4Health: Competence Enhancement in SME |
Call | Medtech4Health: Skills enhancement in small businesses 2023 |
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