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 | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
Purpose and goal
The CE application process has been completed according to the project goals. The underlying processes, documentation, quality measures and structure required for the fulfilment of MDD CE Klas 1 certification have been completed together with added competence of a medical certification expert and IT/GDPR experts. The product has been successfully registered as a MDD CE Klas 1 medical device. The knowledge transfer of quality processes, compliance, regulatory actions and monitoring required for the CE process has been done from the medical expert to the product manufacturer.
Expected results and effects
The product has been successfully registered as an MDD CE Klas 1 medical device. The company is now equipped with internally developed quality and technology management processes to comply with high quality and regulatory requirements related to its product/technology development and maintenance, needed for the risk category of its CE classification. This has led to the product becoming more medically safe and quality assured.
Planned approach and implementation
The certification process consisted of preparation, development of certain quality management and standardization of software development processes. The certification preparation processes also included medical verification, risk analysis of the tool, and technical documentation preparation for the CE application. In addition, GDPR considerations were also made in this process to ensure safe and secure handling and processing of data used in the tool. To support and knowledge transfer was offered by medical certification consultants and GDPR experts.