softgate is EN ISO 13485 certified.
EN ISO 13485 proves compliance with relevant guidelines in the development, implementation, and maintenance of management systems for the medical device industry. It is similar to ISO 9001, but includes additional, specific requirements for medical devices.
softgate is ISO 9001 certified.
ISO 9001 signifies quality assurance through continuous process optimization. It sets out the minimum requirements for a quality management system so that customer requirements for product or service quality can be met.
softgate gmbh’s QMS also meets the requirements of the following standards:
- IEC 62304:2015: Medical device software – software lifecycle processes
- EN 62366:2016: Application of usability to medical devices
- EN ISO 14971:2019: Application of risk management to medical devices