{"id":11753,"date":"2023-01-11T14:58:18","date_gmt":"2023-01-11T12:58:18","guid":{"rendered":"https:\/\/atostek.com\/?page_id=11753"},"modified":"2023-02-14T09:32:46","modified_gmt":"2023-02-14T07:32:46","slug":"laakinnallisten-ohjelmistojen-testaaminen-iso-13485-standardin-mukaisesti","status":"publish","type":"page","link":"https:\/\/atostek.com\/laakinnallisten-ohjelmistojen-testaaminen-iso-13485-standardin-mukaisesti\/","title":{"rendered":"L\u00e4\u00e4kinn\u00e4llisten ohjelmistojen testaaminen ISO 13485 -standardin mukaisesti"},"content":{"rendered":"
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LATAA WHITE PAPER<\/p>\n[\/vc_column_text][vc_column_text]\n

L\u00e4\u00e4kinn\u00e4llisten ohjelmistojen testaaminen ISO 13485 -standardin mukaisesti \u2013 ota huomioon n\u00e4m\u00e4 viisi asiaa<\/b><\/h1>\n

Mit\u00e4 kannattaa ottaa huomioon, kun suunnittelee ja toteuttaa l\u00e4\u00e4kinn\u00e4llisten ohjelmistojen standardien mukaista testausta?
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L\u00e4\u00e4kinn\u00e4llisen ohjelmiston testaus<\/strong><\/h2>\n

L\u00e4\u00e4kinn\u00e4llisell\u00e4 laitteella tarkoitetaan esimerkiksi laitteistoa tai ohjelmistoa, jota k\u00e4ytet\u00e4\u00e4n potilaiden hoitotarkoitukseen. Ohjelmisto voi itsess\u00e4\u00e4n olla l\u00e4\u00e4kinn\u00e4llinen laite tai ohjelmistolla voidaan ohjata l\u00e4\u00e4kinn\u00e4llisen laitteen toimintaa.<\/p>\n

Potilasturvallisuuden kannalta on t\u00e4rke\u00e4\u00e4, ett\u00e4 l\u00e4\u00e4kinn\u00e4lliset laitteet toimivat virheett\u00f6m\u00e4sti. Testauksella on t\u00e4rke\u00e4 rooli l\u00e4\u00e4kinn\u00e4llisen laitteen laadun varmistamisessa, sill\u00e4 virheen pahin mahdollinen seuraus saattaa olla ihmishengen menetys.<\/p>\n

Lis\u00e4ksi l\u00e4\u00e4kinn\u00e4llisen laitteen laatu on otettava huomioon koko sen elinkaaren ajan. Alan laatuvaatimusten tuntemus on t\u00e4rke\u00e4\u00e4, sill\u00e4 l\u00e4\u00e4kinn\u00e4llisten laitteiden valmistajilta vaaditaan EU:ssa MDR-asetuksen mukainen laadunhallintaj\u00e4rjestelm\u00e4, joka vastaa ISO 13485 -standardia.
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Ota n\u00e4m\u00e4 asiat huomioon l\u00e4\u00e4kinn\u00e4llisen ohjelmiston testauksessa<\/b><\/h2>\n[\/vc_column_text][vc_column_text css=”.vc_custom_1673252586232{margin-top: 35px !important;}”]Mit\u00e4 aikaisemmin ohjelmistossa havaitaan vikoja, sit\u00e4 halvempaa niiden korjaaminen yleens\u00e4 on. T\u00e4st\u00e4 syyst\u00e4 testaus tulisi tehd\u00e4 mahdollisimman aikaisessa vaiheessa ohjelmistokehitysprosessia. Mit\u00e4 testisuunnitelman tulisi sitten sis\u00e4lt\u00e4\u00e4? Tai mit\u00e4 j\u00e4ljitett\u00e4vyys tarkoittaa ja miksi se on t\u00e4rke\u00e4\u00e4?<\/p>\n

White paperissa kerromme lis\u00e4\u00e4 l\u00e4\u00e4kinn\u00e4llisten ohjelmistojen testauksesta ISO 13485 -standardin mukaisesti. Nostamme esiin viisi asiaa, jotka tulee ottaa huomioon, kun l\u00e4\u00e4kinn\u00e4llisten ohjelmistojen testausta suunnitellaan ja toteutetaan.<\/p>\n

Lataa white paperimme (englanniksi) ja lue lis\u00e4\u00e4 l\u00e4\u00e4kinn\u00e4llisen ohjelmiston testauksesta![\/vc_column_text][\/vc_column][vc_column typography_style=”white” width=”2\/5″ css=”.vc_custom_1654029897553{background-color: #0d3771 !important;}”][vc_row_inner css=”.vc_custom_1654082795860{padding-top: 10px !important;padding-right: 100px !important;padding-bottom: 10px !important;padding-left: 10px !important;}”][vc_column_inner css=”.vc_custom_1654082774875{margin-top: 10px !important;margin-right: 20px !important;margin-bottom: 20px !important;margin-left: 20px !important;}”][vc_column_text]\n

Download now<\/h2>\n[\/vc_column_text][vc_raw_html css=”.vc_custom_1661166711965{margin-top: 15px !important;}”]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[\/vc_raw_html][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1585071088935{background-color: #84bd00 !important;}” min_height=”305px”][vc_column el_class=”ctablock”][vc_column_text css=”.vc_custom_1673254686567{margin-top: 65px !important;}”]\n

Haluatko kuulla lis\u00e4\u00e4? Kysy lis\u00e4\u00e4 asiantuntijoiltamme!<\/h2>\n[\/vc_column_text][vc_raw_html css=”.vc_custom_1673269459845{margin-top: 30px !important;}”]JTNDYSUyMGhyZWYlM0QlMjIlMkZwYWx2ZWx1dCUyRmxhYWtpbm5hbGxpc3Rlbi1sYWl0dGVpZGVuLW9oamVsbWlzdG9rZWhpdHlzJTJGJTIzbWVkaWNhbHNhbGVzJTIyJTIwY2xhc3MlM0QlMjJuYXBwaSUyMGt1dmFuYXBwaTIlMjIlM0VPVEElMjBZSFRFWVRUJUMzJTg0JTNDJTJGYSUzRQ==[\/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_1661165826556{background: #013453 url(https:\/\/atostek.com\/wp-content\/uploads\/2022\/08\/testing_wp_web.jpg?id=11500) !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_1654028349035{margin-top: 40px !important;margin-bottom: 30px !important;}”][vc_column css=”.vc_custom_1479553360477{margin-bottom: 5px !important;}”][vc_column_text] LATAA WHITE PAPER [\/vc_column_text][vc_column_text] L\u00e4\u00e4kinn\u00e4llisten ohjelmistojen testaaminen ISO 13485 -standardin mukaisesti \u2013 ota huomioon n\u00e4m\u00e4 viisi asiaa Mit\u00e4 kannattaa ottaa huomioon, kun suunnittelee ja toteuttaa l\u00e4\u00e4kinn\u00e4llisten ohjelmistojen standardien mukaista testausta? 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