Standards-compliant software development

Software for medical purposes is developed according to stringent standards worldwide. This ensures that medical products meet the highest safety requirements and that full and proper data validation is carried out. Medical equipment might otherwise malfunction, with potentially grave consequences.  

In line with these requirements, we provide the following services to assist our customers – especially small and medium-sized enterprises – with the market launch of their medical products:

•     Preliminary considerations; feasibility studies according to customer requirements
•     Comprehensive software testing
•     Wide-ranging integration tests for device software
•     Development of a verification and approval strategy

In particular, we focus on ensuring compliance with the following standards:

•     IEC 62304 (Requirements for software life cycle processes)
  
•     IEC 82304 (General requirements for product safety)
•     IEC 62366 (Application of usability engineering to medical devices)
•     DIN EN ISO 14971 (Application of risk management to medical devices)

Not sure whether your medical equipment software complies with all the relevant standards? Just give us a call!