Faster time to market for your medical device or application
Atostek is a leading Finnish expert in medical software. We have an ISO 13485 certified quality management system, and can provide you with an expert team to manage the whole process of creating a finished, approved product, and also to establish and maintain scalable operations in the production phase. We guarantee that our work complies with FDA or MDR regulation!
In addition to expertise in medical software, we have strong competence in the whole business area. We are familiar with the processes, architectures, regulations, and international requirements. We have sound expertise in implementing software for medical appliances and cloud services for the medical data.
Knowledge of health care integrations
Seamless integration is a key element in a health care environment. We ensure compatibility and implement the required solutions to integrate medical devices, applications and information systems. We know the standards in health care, such as HL7 CDA R2, FHIR, DICOM, and XDS.
Some of our clients in the medical device business include Revenio, Novasano, and Nexstim. In addition to software development, we provide consultation with medical device regulation, productization and user experience, and continuous services for scalable operation of back end services utilizing e.g. public cloud technology such as AWS or Azure.