Helen - Medical Communication Device for Equal healthcare

Reference number
Coordinator Worldish AB
Funding from Vinnova SEK 200 000
Project duration August 2019 - February 2020
Status Ongoing
Venture Medtech4Health: Competence Enhancement in SME
Call Medtech4Health: Competence enhancement for smaller companies

Purpose and goal

The purpose of the project is strengthen the company´s competence and knowledge in medical regulatory aspects, quality assurance and CE certification processes needed for its medical product and organization.

Expected results and effects

At the end of the project, the company should have a developed 1)standardised quality management process, 2)medical regulatory knowledge for CE applications and 3)must have a technical file ready to submit for approval for a CE class 1 marking. Additionally the company should be internally better prepared for future regulatory changes and GDPR related aspects. At the end, this would contribute to a safer medical product and a more standardised development and quality control process in the company.

Planned approach and implementation

The project will consist of several workshops together with medical regulatory consultants covering preparation, development of certain quality management, GDPR considerations and standardization of product development processes. The certification preparation processes would also include medical verification, risk analysis of the tool,technical documentation and writing an application for a CE application.

External links

The project description has been provided by the project members themselves and the text has not been looked at by our editors.