WHO defines a medical device as an article, Instrument, device, or machine that is used in the prevention, diagnosis or treatment of illness or disorder, or for detecting, measuring, restoring, correcting or modifying the structure or function of the human body for a certain health purpose? Typically, the objective of a medical device isn’t achieved by pharmacological, immunological, or metabolic means.As a medical device directly contributes to a Health care facility’s ability to correctly assess a patient’s condition, it is crucial for safe and effective prevention, diagnosis, treatment, and treatment of disease and illness.With the Support of medical devices, health care Practitioners have the ability to collect the specific stats of a patient’s health and make medical decisions judiciously.
The growth of digital use in the health care area has paved way for software-enabled medical devices which have brought in a substantial level of sophistication in the contemporary medical device technology.Today, we have advanced pacemakers, insulin Pumps, defibrillators, robotic surgeons and a lot more ground-breaking technologies in the guidance of healthcare practitioners.Since, so much rely on a medical device’s Capability to perform as planned and with precision, even a minor glitch can prove fatal. This is the reason why;it is necessary to conduct comprehensive medical devices testing until they arechannelled for practical usage.To ensure this, there are several regulations and Compliance requirements set up to be fulfilled before a medical device is released on the market. Medical devices testing not only performs the Verification and Validation Vend but also evaluates various facets of the medical device based on functionality, GUI, behaviour, reliability, among other people to stop the use of any faulty device on a patient.
Let’s understand what exactly the Different Kinds Of medical device testing are and what all these types entails. The medical device testing includes an end-to-end Analysis, evaluation, and analysis of any medical device to certify that it functions as planned, does not offer faulty information, and is appropriate for practical use.A properly tested medical device also meets the Required federal and regulatory standards.These are the different types of medical Device testing in regards to a software-enabled medical apparatus. According to FDA, Software verification offers objective proof that the design outputs of a specific period of the software development life cycle fulfil all the specified requirements for this stage. It seems for consistency, completeness, and correctness of this software and its supporting documentation, as it is being developed, and offers support for a subsequent conclusion that software is validated.