{"id":2940,"date":"2016-11-24T11:42:21","date_gmt":"2016-11-24T09:42:21","guid":{"rendered":"https:\/\/atostek.com\/?page_id=2940&lang=en"},"modified":"2024-04-09T14:58:30","modified_gmt":"2024-04-09T11:58:30","slug":"medical-and-health-care-software-old","status":"publish","type":"page","link":"https:\/\/atostek.com\/en\/services\/medical-and-health-care-software-old\/","title":{"rendered":"Software Development for Medical Devices – wanha"},"content":{"rendered":"
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SERVICES<\/p>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=”2\/3″][vc_column_text]\n

Faster time to market for your medical device or application<\/h1>\n

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![\/vc_column_text][vc_column_text]\n

Strong competence<\/h2>\n

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.[\/vc_column_text][vc_column_text]\n

Knowledge of health care integrations<\/h2>\n

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.[\/vc_column_text][vc_column_text]\n

References<\/h2>\n

Some of our clients in the medical device business include\u00a0Revenio<\/a>,\u00a0Novasano<\/a>, 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.[\/vc_column_text][\/vc_column][vc_column width=”1\/3″ css=”.vc_custom_1479554818336{margin-top: 5px !important;}”][vc_column_text css=”.vc_custom_1620808104027{margin-top: 10px !important;border-left-width: 4px !important;padding-top: 12px !important;padding-left: 40px !important;border-left-color: #84bd00 !important;border-left-style: solid !important;}” el_class=”sidebar”]\n

Regulation<\/h3>\n

EU Medical Device Regulation (EU MDR) – CE marking
\nUS FDA Medical Device Regulation<\/p>\n

Standards<\/h3>\n

ISO 13485 – Quality Management
\nIEC 62304 – Sofware Lifecycle
\nISO 14971 – Risk Management
\nIEC 62366 – Usability<\/p>\n

Integration technologies<\/h3>\n

DICOM
\nHL7 CDA R2
\nIHE XDS
\nFHIR[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1479551849927{background-color: #84bd00 !important;}” min_height=”305px”][vc_column el_class=”ctablock”][vc_column_text css=”.vc_custom_1479980382950{margin-top: 65px !important;}”]\n

Would you like to hear more about our medical and health care services?
\nPlease contact us and we will get back to you.<\/h2>\n[\/vc_column_text][vc_raw_html css=”.vc_custom_1523277123330{margin-top: 30px !important;}”]JTNDYSUyMGhyZWYlM0QlMjIlMkZlbiUyRmNvbXBhbnklMjN5aHRleXMlMjIlMjBjbGFzcyUzRCUyMm5hcHBpJTIwa3V2YW5hcHBpMiUyMiUzRUNPTlRBQ1QlMjBVUyUzQyUyRmElM0U=[\/vc_raw_html][\/vc_column][\/vc_row]\n<\/section>","protected":false},"excerpt":{"rendered":"

[vc_row full_width=”stretch_row” min_height=”305px” css=”.vc_custom_1480352723338{background-image: url(https:\/\/atostek.com\/wp-content\/uploads\/2016\/11\/laaketede2.jpg?id=2769) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1479553166822{margin-top: 105px !important;}”][vc_column css=”.vc_custom_1479553360477{margin-bottom: 5px !important;}”][vc_column_text] SERVICES [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=”2\/3″][vc_column_text] 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…<\/p>\n","protected":false},"author":6,"featured_media":0,"parent":8151,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false},"_links":{"self":[{"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/pages\/2940"}],"collection":[{"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/comments?post=2940"}],"version-history":[{"count":2,"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/pages\/2940\/revisions"}],"predecessor-version":[{"id":15198,"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/pages\/2940\/revisions\/15198"}],"up":[{"embeddable":true,"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/pages\/8151"}],"wp:attachment":[{"href":"https:\/\/atostek.com\/en\/wp-json\/wp\/v2\/media?parent=2940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}