Medical Device Software Validation

Every businesses workhas   complex compliance requirements, from anti-money laundering laws to consumer protection, labelling safety and environment protection.Similarly, there is very highly regulated pharmaceutical industry and medical device business must comply not only local laws but also of the countries where they are exporting. This compliance is not just on product quality claim by manufacturer but must meet all requirement like manufacturing its environment, testing, various other actual testing on human called clinical trial where needed. Business must comply with all compliance requirement otherwise consequences are severe like not just financial loss, business closure but also punishment of imprisonment to certain direct people. Let us talk about Medical device business compliances. They are majorly divided into two areas where manufacturing compliance requirement is there and other is directly dealing with regulatory authorities’ time to time basis for ever cha...

First and foremost, question must have to mind that why MDD was to be re-written in the form of MDR. Regulation keep changing through periodic updating, but this is major change where many changes were incorporated in new document called Medical device regulation (MDR) The European (MDR) is going to be a new set of regulations that governs the assembly and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products within the European marketplace . 1.           Why did the MDD need an update? With the progress of IT industry, more and more software started coming and its use in medical device also started. This came into form of an application or governing medical devices where patient can also see his/her own monitoring. During old days when MDD was written this did not exist. So, need to regulate such development, MDR was born. There is a growing push for transparen...

  If you are medical device manufacturer and you are now you think you are ready with medical device and wants to launch in the Market. Some time you may not have regulatory back up to do job on your own and you may think of hiring consultant. No Issues, this is what most companies do. Steps to follow to bring to market are same for long period of time like normal documented process from design to release in the market. You may feel easier job, but do you know that regulation you have read and tried to comply successfully has changed now? These are happening every now and then based on feedback of users and medical device professionals. Regulatory bodies like US FDA and EU MDR act and change regulation in the interest of patients who are real impacted people. This is where role of consultant competency counts. Choose consultant but do ask them following question before hiring. 1. HAVE YOU HELPED A COMPANY PASS OUR REGULATORY STANDARDS? If yes, which one US FDA, EU MDR? 2....

  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...