[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"site-settings":3,"blogpost-what-is-software-as-medical-device-and-why-it-matters":72},{"footer":4,"contact_form":6,"chat_widget":11,"accolades":19,"seo_social":63},{"iso_notice":5},"Wolfpack Digital is an ISO 9001:2015, ISO 27001:2013 and ISO 14001:2015 certified company - © _YEAR_ Wolfpack Digital. All rights reserved.",{"budgets":7},[8,9,10],"Under $50.000","Between $50.000 - 200.000","Over $200.000",{"consent":12},{"greeting":13,"title":14,"body":15,"accept_label":16,"decline_label":17,"declined_message":18},"Awoo! I'm Wolfpack Digital's AI assistant. Ask me anything about our services, process, or team, and if you want a project estimate, I can point you to our AI Estimator.","Data Privacy","\u003Cp>Hi there! We would love to talk with you. Under the EU General Data Protection Regulation, we need your approval for our use of personal information (e.g. your name and email address) you may provide as we communicate:\u003C\u002Fp>\n\u003Col>\n  \u003Cli>We'll store your personal information so that we can pick up the conversation if we talk later.\u003C\u002Fli>\n  \u003Cli>We may send you emails to follow up on our discussion here.\u003C\u002Fli>\n  \u003Cli>We may send you emails about our upcoming services and promotions.\u003C\u002Fli>\n\u003C\u002Fol>\n\u003Cp>Is this okay with you?\u003C\u002Fp>","Yes, I Accept","No, Not Now","No problem. Come back if you change your mind.",{"winnersOfList":20,"awardsList":29,"inHouseAppImages":46,"certificationsList":50},[21,25],{"alt":22,"href":23,"image":24},"European Awards","https:\u002F\u002Fwww.theeuropeanawards.eu\u002Fpremiado\u002Fwolfpack-digital-awarded-in-the-app-development-category","\u002Fimages\u002Fabout-us\u002Fwinners\u002Feuropean.svg",{"alt":26,"href":27,"image":28},"Webby Awards","https:\u002F\u002Fwinners.webbyawards.com\u002F2024\u002Fwebsites-and-mobile-sites\u002Fresponsible-technology\u002Fresponsible-ai\u002F275408\u002Fequality-ai-fair-and-unbiased-algorithms-to-eliminate-discrimination-in-machine-learning-models","\u002Fimages\u002Fabout-us\u002Fwinners\u002Fwebby.svg",[30,34,38,42],{"alt":31,"href":32,"image":33},"Clutch 1000 List Reveals Top-Rated Business Service Providers of 2023","https:\u002F\u002Fclutch.co\u002Fpress-releases\u002Fclutch-1000-fall-2023","\u002Fimages\u002Fabout-us\u002Fawards\u002Fclutch.svg",{"alt":35,"href":36,"image":37},"Clutch Recognizes the 1000 Best B2B Service Providers in its Exclusive 2019 Clutch 1000 List","https:\u002F\u002Fclutch.co\u002Fpress-releases\u002Frecognizes-1000-best-b2b-service-providers-its-exclusive-2019-1000-list","\u002Fimages\u002Fabout-us\u002Fawards\u002Fglobal.svg",{"alt":39,"href":40,"image":41},"Mobile App Daily Award","","\u002Fimages\u002Fabout-us\u002Fawards\u002Fmobile-app-daily.svg",{"alt":43,"href":44,"image":45},"Manifest Award","https:\u002F\u002Fthemanifest.com\u002Fro\u002Fweb-development\u002Fcompanies","\u002Fimages\u002Fabout-us\u002Fawards\u002Fmanifest.svg",[47],{"alt":48,"href":40,"image":49},"Wolfpack Labs","\u002Fimages\u002Fhomepage\u002Fawards\u002Flabs.svg",[51,55,59],{"alt":52,"href":53,"image":54},"ISO 27001 Certification","https:\u002F\u002Fwww.qscert.com\u002Fcs\u002Fissued-certificates\u002F?certID=_7690LD367","\u002Fimages\u002Fabout-us\u002Fcertifications\u002Fiso-27001.svg",{"alt":56,"href":57,"image":58},"ISO 9001 Certification","https:\u002F\u002Fwww.qscert.com\u002Fcs\u002Fissued-certificates\u002F?certID=_7690LBDB0","\u002Fimages\u002Fabout-us\u002Fcertifications\u002Fiso-9001.svg",{"alt":60,"href":61,"image":62},"ISO 14001 Certification","https:\u002F\u002Fwww.qscert.com\u002Fma\u002Fissued-certificates\u002F?certID=_7690LZSGS","\u002Fimages\u002Fabout-us\u002Fcertifications\u002Fiso-14001.svg",{"default_og_image_urls":64,"default_og_image_alt":68,"og_site_name":68,"og_locale":69,"twitter_site":70,"page_type_defaults":71},[65],{"url":66,"style":67},"\u002Fimages\u002Fsocial_share_preview.jpg","og","Wolfpack Digital","en_US","@DigitalWolfpack",{},["Reactive",73],{"title":74,"body":75,"slug":76,"featured_image_urls":77,"meta_tags":102,"reading_time":109,"title_size":110,"tag_list":111,"formatted_published_at":116,"short_description":103,"categories":117,"alt_text":118,"published_at":119,"content_updated_at":118,"formatted_content_updated_at":118,"key_takeaways":120,"faqs":121,"updated_at":122,"canonical_override":118,"no_index":123,"canonical_url":124,"publishers":125},"What is Software as Medical device and why it matters","\u003Cp>\u003Cmeta charset=\"utf-8\">\u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp>Emerging technologies and digitalization have a huge impact in the healthcare industry as they can streamline processes, increase transparency, ease communication between all parties, improve response times and provide quick diagnoses. \u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp>Software solutions are the core of multiple MedTech apps and HealthTech solutions, and they are integrated across a variety of products and platforms - be it medical or non-medical. \u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Ch1>What types of software solutions are related to medical devices? \u003C\u002Fh1>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp>There are 3 types of software solutions related to medical devices:\u003C\u002Fp>\r\n\r\n\u003Cul>\r\n\t\u003Cli>software \u003Cstrong>as\u003C\u002Fstrong> a medical devices\u003C\u002Fli>\r\n\t\u003Cli>Software\u003Cstrong> in\u003C\u002Fstrong> a medical device\u003C\u002Fli>\r\n\t\u003Cli>software used in the manufacture or maintenance of a medical device\u003C\u002Fli>\r\n\u003C\u002Ful>\r\n\r\n\u003Ch1>What is Software as a medical device and how can you use it? \u003C\u002Fh1>\r\n\r\n\u003Cp>\u003Ca href=\"http:\u002F\u002Fwww.imdrf.org\u002Fdocs\u002Fimdrf\u002Ffinal\u002Ftechnical\u002Fimdrf-tech-131209-samd-key-definitions-140901.pdf\" target=\"_blank\">Software as a Medical Device\u003C\u002Fa> is described by the \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fcdrh-international-programs\u002Finternational-medical-device-regulators-forum-imdrf\" target=\"_blank\">International Medical Device Regulators Forum (IMDRF)\u003C\u002Fa> as \"\u003Cstrong>software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.\"\u003C\u002Fstrong>\u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp>\u003Cstrong>Software as a Medical device examples:\u003C\u002Fstrong>\u003C\u002Fp>\r\n\r\n\u003Cul>\r\n\t\u003Cli>Software solutions used for Screening, diagnosis, treating, alleviating, or preventing different conditions.\u003C\u002Fli>\r\n\t\u003Cli>Mobile applications to monitor, alert and facilitate patients’ pain management, arrhythmia management, and blood glucose monitoring. \u003C\u002Fli>\r\n\t\u003Cli>Apps used for Chronic condition and disease management\u003C\u002Fli>\r\n\t\u003Cli>Any solution, be it web or mobile, used for digital therapeutics\u003C\u002Fli>\r\n\u003C\u002Ful>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp>\u003Cstrong>To put it bluntly, s\u003C\u002Fstrong>oftware as a Medical Device can be anything from a mobile app to any software that helps patients, by functioning independently from another \u003Cstrong>medical device hardware; It can use the data from a device, but it is not connected to it. \u003C\u002Fstrong>\u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp>Think about all the software solutions helping the medical staff to analyze X-rays and MRIs - while there are plenty of devices to take a scan, there are also plenty of software solutions helping you diagnose conditions based on the results. \u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Ch1>What is Software in a medical device, and how common is it?\u003C\u002Fh1>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cul>\r\n\t\u003Cli>Software\u003Cstrong> in\u003C\u002Fstrong> a medical device\u003C\u002Fli>\r\n\u003C\u002Ful>\r\n\r\n\u003Cp>to keep the example we've mentioned above, there are multiple software solutions to help radiologists diagnose different conditions when they check a scan, but the software that transforms the MRI magnets into an Xray or something you can look at or if we are thinking about an interface to control the device, then we are looking at Software in a Medical Device. \u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Ch2>Build Your Software as a Medical Device with us\u003C\u002Fh2>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp>We have what it takes to build health apps for prevention, diagnosis, intervention, treatment, recovery, and patient management & communication, and we look forward to working on the next meaningful medical software, especially in these times.\u003C\u002Fp>\r\n\r\n\u003Cp>  \u003C\u002Fp>\r\n\r\n\u003Cp>\u003Cstrong>We really know how to work with health professionals\u003C\u002Fstrong>! \u003C\u002Fp>\r\n\r\n\u003Cp>Got a health startup, or are you looking to digitalize any health services or any part of the medical act? Get in touch with us and \u003Ca href=\"https:\u002F\u002Fwww.wolfpack-digital.com\u002Fcontact\" target=\"_blank\">let’s talk\u003C\u002Fa>! \u003C\u002Fp>\r\n\r\n\u003Ch1> \u003C\u002Fh1>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n\r\n\u003Cp> \u003C\u002Fp>\r\n","what-is-software-as-medical-device-and-why-it-matters",[78,81,84,87,90,93,96,99],{"style":79,"url":80},"640","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002F640\u002Fimage_processing20220615-4-dmwvf5.webp",{"style":82,"url":83},"768","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002F768\u002Fimage_processing20220615-4-dmwvf5.webp",{"style":85,"url":86},"1024","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002F1024\u002Fimage_processing20220615-4-dmwvf5.webp",{"style":88,"url":89},"1366","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002F1366\u002Fimage_processing20220615-4-dmwvf5.webp",{"style":91,"url":92},"1600","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002F1600\u002Fimage_processing20220615-4-dmwvf5.webp",{"style":94,"url":95},"1920","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002F1920\u002Fimage_processing20220615-4-dmwvf5.webp",{"style":97,"url":98},"thumb","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002Fthumb\u002Fimage_processing20220615-4-dmwvf5.webp",{"style":100,"url":101},"original","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fblogpost\u002F142\u002Ffeatured_image\u002Foriginal\u002Fimage_processing20220615-4-dmwvf5.webp",{"title":74,"description":103,"keywords":104,"contact_form:title":105,"contact_form:cta":106,"og:site_name":68,"og:type":107,"og:locale":69,"twitter:card":108,"twitter:site":70,"twitter:creator":70,"og:title":74,"twitter:title":74},"What is Software as a medical device and how can you use it? A short article about all types of software solutions and their relation to medical devices.","samd, software as medical device, what is software as medical device, healthcare app development","contact us","send message","article","summary_large_image","3 min",32,[112,113,114,115],"Healthcare","medtech","healthtech","SaMD","Oct 28, 2021",[114],null,"2021-10-28T07:35:00.000Z",[],[],"2022-06-16T09:02:29.148Z",false,"https:\u002F\u002Fwd-fe-stage.herokuapp.com\u002Fblogposts\u002Fwhat-is-software-as-medical-device-and-why-it-matters",[126],{"id":127,"author":128,"short_description":129,"role":130,"avatar_urls":131,"cover_urls":118,"linkedin_link":118,"instagram_link":118,"x_link":118,"meta_tags":139,"last_published_at":141,"same_as":142},7,"Corina ","Coffee fueled Marketing Strategist for tech products","Chief Marketing Officer",[132,134,137],{"style":97,"url":133},"https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fpublisher\u002F7\u002Favatar\u002Fthumb\u002Fcorina_stirbu-CMO-wolfpack-digital.webp",{"style":135,"url":136},"medium","https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fpublisher\u002F7\u002Favatar\u002Fmedium\u002Fcorina_stirbu-CMO-wolfpack-digital.webp",{"style":100,"url":138},"https:\u002F\u002Fwolfpack-digital-attachments-staging.s3.eu-west-2.amazonaws.com\u002Fstore\u002Fpublisher\u002F7\u002Favatar\u002Foriginal\u002Fcorina_stirbu-CMO-wolfpack-digital.webp",{"title":40,"description":40,"keywords":40,"contact_form:title":105,"contact_form:cta":106,"og:site_name":68,"og:type":140,"og:locale":69,"twitter:card":108,"twitter:site":70,"twitter:creator":70},"website","2021-11-23T06:45:59.000Z",[]]