CE registration RETTS Plus

Purpose and goal

The purpose of the project was to obtain a CE marking of RETTS Plus and at the same time secure Predicare´s regulatory ability to CE mark and maintain CE marking of digital tools for emergency care. In relation to the project´s original milestones and associated activities, the degree of fulfilment is estimated to be approx. 70%. As the understanding of the requirements became clear, work that was not part of the original project plan had to be added.

Expected results and effects

The project results include 1. Introduction of a digital quality management system with relevant parts according to ISO13485 2. Steering documents, esp. regarding software development, risk management and feedback from the market 3. Reporting documents that match point 2 above. The effect of the project is an increased ability of the company to handle CE marking of software as a medical device. CE marking of the product remains as not all details are in place yet. This is expected to take place during Q1, 2019.

Planned approach and implementation

The approach was to CE mark according to MDD 93/42 / EEC, class 1 and to future-proof the CE marking by following the requirements of MDR 2017/745. In the original project plan, 14 milestones were defined. The work had to be partly adapted as new aspects were added that required expertise from several external resources other than from the originally hired consulting firm. The scope was greater than the initial estimate and required the entire company´s commitment.