LinnéFiler - a CE certified product

LinnéFiler is a CE certified Class I medical device in accordance with SE MDD 2003:11 and EU MDR 2017/745.

The certification means the design and development process of the product is held to a higher standard than other software. The main benefits of the software being a CE certified product:

Risk management
The design and development process is highly integrated with our risk management program. Each tiny development as well as every major release is risk managed in order to minimize the risk of errors, faults and to maximize user and patient safety. Risk assessment is performed for each release and documented according to regulation.

Testing
Everything is tested! Every individual development case added or modified in a development cycle is tested for functionality and every release goes through a rigorous system wide usability test. Testing ensures that the product delivered is free from bugs and errors and allows for a higher quality product.

Documentation
CE certification requires a documentation trail for the development, testing and risk assessments made throughout the development process. Outside the process of developing LinnéFiler the certification also requires the company to adhere to best practices when it comes to quality and management. Fertsoft uses a management system developed using the ISO 13485 standard.

Adherence to standards
In the development of LinnéFiler we follow standards in order to increase quality. Our management system is based on ISO 13485. We also work with the demands stipulated by ISO 27001 when it comes to information security. Besides the general standards used in our day to day work the following standards are used specifically in development:

StandardPurpouse
ISO15223-1Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO14971Medical devices - Application of risk management to medical devices
EN1041+A1Information supplied by the manufacturer of medical devices
EN62304Medical device software - Software life-cycle processes
EN62366 A1Medical devices - Part 1: Application of usability engineering to medical devices