Development of medical software requires additional expertise in project planning and implementation. According to the European regulation IEC-62304 medical software producers must have a more qualitative approach when developing systems for medical purposes.
According to the German Act on Medical Devices it is indispensable to continuously apply risk management during all the phases of product development. Also, product testing and validation should be systematized in appropriate way and require competent expertise in quality assurance.
Due to great responsibility as well as to legislative requirements to the processes and documentation, medical software development is more labor intensive than agile development of standard projects with minimum of documentation. Experience and expertise in the subject area and in relevant production processes play crucial role as they help to save lots of recourses.
Our specialists have a long-term experience in medical program development including the following subject areas:
- Medical drug databases: red list, ABDA
- Diagnosis classification: Alpha-ID, ICD-10-GM
- Disease symptoms: in-house development of database with relation between a symptom and a diagnosis (in progress)
- Interfaces for data exchange: HL7, Healthvault
Our specialists certified as Professionals for Medial Software (CPMS) have already gained considerable experience in developing and certificating medical software that has been authorized as a medical product in the European clinics.