{"id":14815,"date":"2020-08-13T20:42:32","date_gmt":"2020-08-13T15:12:32","guid":{"rendered":"https:\/\/cigniti.com\/blog\/?p=14815"},"modified":"2022-07-28T14:07:48","modified_gmt":"2022-07-28T08:37:48","slug":"types-of-medical-device-testing","status":"publish","type":"post","link":"https:\/\/www.cigniti.com\/blog\/types-of-medical-device-testing\/","title":{"rendered":"Understanding the different types of medical device testing"},"content":{"rendered":"
WHO defines a medical device as a<\/span>n article, instrument, apparatus<\/span>,<\/span>\u00a0or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological<\/span>,<\/span>\u00a0or metabolic means.<\/span>\u00a0<\/span><\/p>\n As a medical device directly contributes to a healthcare facility\u2019s ability to accurately evaluate a patient\u2019s condition, it is essential for safe and effective prevention, diagnosis, treatment, and rehabilitation of illness and disease.<\/span>\u00a0<\/span><\/p>\n With the help of medical devices, healthcare practitioners are able to collect the exact stats of a patient\u2019s health and make medical decisions judiciously. The rise of digital usage in the medical space has paved way for software-enabled medical devices that have brought in a significant degree of sophistication in the modern medical device technology.<\/span>\u00a0<\/span><\/p>\n Today, we have innovative pacemakers, insulin pumps, defi<\/span>brillators, robotic surgeons and many more groundbreaking technologies at the assistance of healthcare practitioners.<\/span>\u00a0<\/span><\/p>\n Since, so much rely on a medical device\u2019s capability to perform as intended and with precision, even a minor glitch can prove fatal. This is why, it is important to conduct thorough medical devices testing before they are channeled for practical use.<\/span>\u00a0<\/span><\/p>\n To ensure this, there are several regulations and compliance requirements in place to be fulfilled before a medical device is released in the market.\u00a0<\/span>Medical devices testing<\/span><\/a>\u00a0not only performs the Verification & Validation (V&V) but also evaluates various aspects of the medical device based on performance, GUI, behavior, reliability, among others to prevent the usage of any faulty device on a patient.<\/span>\u00a0<\/span><\/p>\n Let us understand what exactly the different types of medical device testing\u00a0<\/span>are\u00a0<\/span>and what each of those types entails:<\/span>\u00a0<\/span><\/p>\n Types of medical device testing<\/span><\/b>\u00a0<\/span><\/p>\n Medical device testing includes an end-to-end analysis, assessment, and evaluation of any medical device to certify that it performs as intended, does not provide faulty information, and is fit for practical usage.<\/span>\u00a0<\/span><\/p>\n A properly tested medical device also meets the required federal and regulatory criteria.<\/span>\u00a0<\/span><\/p>\n These are the<\/span>\u00a0different types of medical device testing when it comes to a software-enabled medical device:<\/span>\u00a0<\/span><\/p>\n Medical Devices Testing \u2013 A case study<\/span><\/b>\u00a0<\/span><\/p>\n With the objec<\/span>ti<\/span>ve of simplifying and customizing delivery of complex drug regimens,\u00a0<\/span>an innovative medical device manufacturer developed a first-of-its-kind technology for insulin delivery methods. The company was looking for\u00a0<\/span>end-to-end testing & quality engineering services<\/span>\u00a0from an organization that could provide a robust framework for integrating so<\/span>ft<\/span>ware, mobile devices, and medical devices<\/span>.\u00a0<\/span>\u00a0<\/span><\/p>\n Cigniti ensured both high quality & compliance for the client\u2019s medical devices<\/span>\u00a0by establishing QA best practices and reducing their test time by more than 50%.\u00a0<\/span>Read the complete success story of that medical device manufacturer<\/span><\/a>.<\/span>\u00a0<\/span><\/p>\n How can we help<\/span><\/b>\u00a0<\/span><\/p>\n Cigniti is an ISO13485:2016 certified organization & the chosen Software Testing services partners for large Medical Device manufacturers and users. We help you address challenges in Medical device software testing and also in implementing guidelines & best practices in software testing lifecycle of these devices.<\/span>\u00a0<\/span><\/p>\n Our dedicated Medical Devices Testing CoE experts help Verify & Validate Software for surgical instruments, contact lenses & ultrasound scanners, orthopedic implants & haemodialysis machines, cardiac pacemakers. They are fully capable of helping clients test their smart, AI-based medical & healthcare devices such as intelligent beds, sterilization equipment, tool kits for pets, and more.<\/span>\u00a0<\/span><\/p>\n\n
\nOn the other hand,\u00a0FDA considers software validation to<\/span>\u00a0<\/span>be \u201cconfirmation by examination and provision of objective evidence that software<\/span>\u00a0<\/span>specifications conform to user needs and intended uses, and that the particular requirements<\/span>\u00a0<\/span>implemented through software\u00a0<\/span>can be consistently fulfilled.\u201d<\/span>\u00a0<\/span><\/li>\n