Software development Profundus AB

Important results from the project

The goal of the project was to ensure that regulations and standards for the software in the product were met. This is a crucial part of achieving CE marking and subsequent industrialization. Templates and processes developed that will be used in future project in the organization and the knowledge transfer to project participants and the rest of the organization means a better understanding and maturity for future project.

Expected long term effects

New knowledge and understanding of how medical device product development needs to be done to meet regulations and standards, which is a crucial part of being able to put a product on the market. Templates and processes that have been developed will be used in future project in the organization to meet legal requirements and industry standards. With the help of the effort in the project, the company has reached a new maturity for the next step in building a medical device company in the region.

Approach and implementation

Development of processes & templates for SW development (part of the quality system), was developed and adapted to the Profundus quality system and requirements. The consultants have guided and supported in the development of the technical documentation required to demonstrate regulatory compliance. A Development Plan, Requirement Spec, Risk Assessment and SW architecture have been developed. The system has been finalized and is almost ready for internal formal verification.