Medical Device Software Validation

  AI Technology is making its presence in many fields now a days with advancement of IT. Medical field and specifically medical device field is also accepting that technology. You must be aware that AI is mimicking human mind like reasoning, learning and problem solving in simple language recognising some objects, doing translation of language in truer sense and not merely word translation which is based on feed data. Now you can imagine this great IT based technology to be used for medical treatment hence the reliability has to be great. Since lot of progress has been made    with AI technology and its use started in medical devices , regulators may consider multiple approaches for addressing the security and effectiveness of AI in healthcare, including how international standards and other best practices are currently wont to support the regulation of medical software.This is not an easy taskas it is going to be the necessity to get actual   clinical evidence...

  A pre-market clinical investigation, namely, a clinical investigation with a device that has not yet been CE marked. MDR has come out quite additional requirement which were not there in MDD earlier. MDR describes a set of technical and/or clinical requirements, aside from a typical, that gives a way of complying with the legal obligations applicable to a tool, process or system.’ The MDR sets out very detailed requirements regarding clinical investigations as compared with the Directives. MDR Articles 62 through 80 address: MDR requirement may look familiar as they are very similar to European harmonised standard BS EN ISO 14155-2011. 1. general requirements regarding clinical investigations conducted to demonstrate conformity of devices. Clinical investigation will have to comply with National competent authorities and Ethics committee. Sponsor requirement has also come. (Refer detail about sponsor and ethics committee requirement) 2.   Informed consent with relev...

EU MDR I general guideline document applying to all medical devices marketed in Europe however for UK MHRA has come out with new guideline which has to be followed if product must be marketed in Great Britain (This contains England, Wales and Scotland) like CE Mark which is recognised for Europe UKCA mark will be required for product marketed in Great Britain. (CE marked product will be allowed till June 30,2023) UKCA stands for UK Conformity Assessed. The new guideline replaces previous guideline. This is helpful for developer as well as user as it gives various examples to fall standalone software into medical device or not. The guidance is meant to assist developers of software and apps in navigating the regulatory system so as that they are conscious of the procedures. With rapid progress of development of software for diagnosing, predicting and advisory software based on data entered or captured from another device when connected, all need to be controlled and thus covered u...

  Post-market surveillance is an important element for any medical device. All national and international communities associated with medical device has given stress on this study as mandatory and reporting of adverse events to authority is also mandatory. This is continuous and helps us develop new improvement and let us compare the performance of equivalent devices in the market and lets us know the risk assessment and its rationality. Medical devices are released based on risk benefit analysis thus all carry some residual safety and performance risk throughout their life cycle.   These risks as arise from a couple of things that include product variability, factors affecting the product’s use environment and different end-user interactions, furthermore as unforeseen device failure or misuse. Of course, product design and development activities normally take care all above factors in   design to make sure that any residual risk is suitable before product release...

  Biological evaluation is an essential part of medical device right from the beginning and there are lot of advancement happening as the progress in technology happens and the experience that gained over a period in this field. It goes without saying that people got to be shielded from the potential biological risks that would arise from the utilization of medical devices, yet the range of biological hazards is wide and sophisticated. There is a standard existed BS EN ISO 10993-1-2009, and this was required to be followed as guideline however there were various separate method were used for actual evaluation depending on device type.   Recently EN ISO 10993-1:2020 – was published which covers the biological evaluation of medical devices within a risk management process as a part of the general evaluation and development of every medical device . This is mainly because international safety standard on medical device under risk management process also underwent massive revi...

 The healthcare and specifically medical device industry today is not what it had been just five years ago. Thanks to technology development and an innovative digital solutions All these developments are contributory from various fields like Information technology where software for managing devices accurately and data collection and its use by doctor remotely. Imagine the advantages of this technology during this corona pandemic where online consultation helped lot of patients where acquired data from device was sent to doctor for study, monitoring and additional diagnosis if required. Let us further examine the technology development and its benefit. 1.                                lot of Patient Data: data generated from measurement with software to convert them in desired pattern for doctor or nurses to take care of pati...

  I hate Risk Management. There, I said it. And I am not the only one actually. Many of us are thinking that the Risk management is terrible! Please note that Risk Management is integral part of medical device and nobody can do away with this, so it needs t be embraced. With feeling of hate it will be difficult to implement this process with true potential. This system, no doubt is slightly complex and requires some training and in-depth knowledge for its application. Once done then life becomes easy. It is confusing and lengthy to induce through. you have got no real idea if you’ve covered everything or if you would like to stay going further. And once you get into probabilities and severities, it seems like you are just guessing. Though this is true but once mind change happens and you start using the same you learn a lot. Couple of guideline documents are available. ISO standard 14971-2019 is latest standard on this which also describes a lot about what is risk assessment. ...