16. July 2018


For softgate, quality management plays a crucial role. By regular participation in audits, we review and confirm our performance and quality. Thus, we always meet the strict ISO 9001 and ISO 13485 standards in software development, for example for medical technology.

softgate is ISO 13485 certified.
ISO 13485 proves compliance with the relevant guidelines for development, implementation, and maintenance of medical product management systems. It is similar to ISO 9001, but includes additional and specific requirements for medical products.

softgate is ISO 9001 certified.
ISO 9001 stands for quality assurance by continuous process optimization. It defines the minimum requirements for a quality management system to fulfil customer requirements and product quality or service quality requirements.