Strengthening of regulatory competence

Important results from the project

Pressure ulcer is a major problem that causes both patient suffering and high costs for the health care system. Today about 14% of all hospitalized patients suffer from pressure ulcers and half of these have not been identified as risk patients and therefore have not received any preventive measures. Today´s risk assessment is subjective imprecise. PUsensor´s goal is to improve the risk assessment and thereby reduce the amount of pressure ulcers. The aim of this project was to strengthen our regulatory competence to enable CE-marking of our product, which has been achieved.

Expected long term effects

Now at the end of the project, PUsensor has the capability to CE mark its product in terms of quality management and knowledge of the requirements that need to be met, such as technical documentation.

Approach and implementation

The project started with the setup of a preliminary quality management system(QMS) and staff training in this as well as a structured approach to work with quality management. Thereafter the project continued with a focus on technical documentation, reviewing all that need to be included in the CE marking and training of the staff in this. The differences between MDD and MDR has also been handled Support from Medos has been had during the entire project.