Software development Profundus AB

Purpose and goal:

Today there is a great and pronounced need to quickly and easily examine the retinal structures. Profundus is developing a camera solution that is controlled by a software function which will be documented in the project. The CE marking process includes the establishment and implementation of a quality management system for medical device software. The project will lead to compliance with regulations and standards for this software, which is a crucial part of achieving CE marking.

Expected results and effects: The project will lead to compliance with regulations and standards

for the medical device software in the product, which gives the opportunity to achieve CE marking and thus market introduction and sales within the EU. Approach and implementation: The expert consultant helps and supports Profundus staff in the development of: • Processes to be included in the quality system

• Templates/forms to be included in the quality system • Software Development Plan • Requirement Specification • Risk Assessment incl cybersecurity • Software architecture

Project meetings will be held for a full day once a week. In between, individual work with support if necessary. Reporting from the sub-project to Profundus´ internal functions every week.