Definition of healthcare service objectives and medical/non-medical certification roadmap

03-02-20 Rongbo Hu 0 comment

REACH has defined the medical goals and purposes for its major systems and subsystems more clearly. The medical professionals in the project were involved to specify the medical purpose and intended use, external members of standardization and certification bodies were involved to develop a clinical evaluation plan. Based on this information the relevant standards and risks were identified, and a certification roadmap was developed. The planned certification levels and classes were specified for all systems and sub-systems.


IMG_8337-002



Leave a reply