In this week's lectures in this week four, we're going to talk about two technologies that support the development of medical software. We're going to talk about quality management systems and risk management. So our objectives are to cover quality manage system and risk management. These are the supporting technologies that underlie all of this development. All the work in medical software happens within the context of quality management systems and index. Under the support under the guidance of a risk management procedure, we have six segments. The first one will introduce quality management systems. The next two will review this very important guidance document from the IMDRF and called the management systems. Then we introduce risk management and then we'll have two more segments to describe the risk management process. For extra reading, you can go to the textbook to look at chapters four and quality management System and five on risk management. And this is where the materialist lecture comes from. So quality management systems. Let's introduce the topic here. The American Society for Quality defines this as. The quality management system is defined as a formalized system. The documents, processes, procedures and responsibilities for achieving quality policies and objectives. A QMS, helps to coordinate direct an organizations activities to meet customer and regulatory requirements and to improve its effectiveness and efficiency on taken on a continuous basis. It's a rule book for the company and completely as well here in the video clip that coming up, it's just a set of standard operating procedures that tells us how to do things. So if you want some other secure messages, we have to do the right thing the right way by following an explicit plan in an appropriate environment. That's kind of my somebody and for a little bit more of a discussion. And this will have a video clip from dr fan liu from the product of physiology laboratory that will tell us a little bit more about this. >> It is a set of procedures. The procedures make up a system, the procedures ensure that you manage the development of the product from conception all the way to the end when it gets out into the customers and that as the customers are using it, their experiences are systematically fold back into your evaluation of your device. The goal of all of it is to demonstrate that whatever you're building, whether it's software, hardware or a pharmaceutical agent or whatever that it is safe and effective. Those are the two key words safe and effective that the regulatory bodies are concerned with when they evaluate your device and to effectively evaluate your device and have confidence. They want to know if you follow best practices and that's the quality management system. >> So defining quality management system what these best practices have from medical software. Our first source of the three international standards that are relevant to this area. ISO 9001 is the parent standard for quality management systems. This applies to any kind of business. There's a set of guidelines from the ISO 90003 Which is the guidelines for the application of ISO 9001 to computer software and finally, the most critical one for us is ISO 13485 which is a quality management system medical device standard. And this is what forms the basis of much of the cure mess and many companies used for medical software. The FDA has its own quality management systems rules. If you go back to college system regulation here is the definition they use quality system means that the organization structure, responsibilities, procedures, processing resources from implementing quality management is the whole thing. This is what the quality management system is. It's similar in spirit to ISO 13485. We'll have more on this later and there's some diversions but all of these things are in the process of harmonization. So If we discuss the ISO 13485, most of what you hear is very similar to the details of what the FADA requires. And in fact, we may get closer over time just to take a look again at the european regulation. This is what a cure mess has to be according to the M DR Are the medical device regulation? This a little bit more detail than what the FDA has. Just just look at the 10 components here has to include a strategy for compliance identification of applicable general safety and performance requirements, an exploration of options to address this responsibility of the management will come back to this. Resource management including selection, control of suppliers and subcontractors. This is an important component, especially in software risk management, clinical evaluation, including critically PMC F post market clinical follow up product realization including planning, design, development, production and service provision verification, unique device identifiers, setting up implementation and maintenance of post market surveillance systems. And the list goes on to handling communication with competent authorities. The government agencies that monitor you processes for reporting of serious incidents and feel corrective actions. Management of corrective and preventative actions with verifications with their effectiveness. And then the final step processes for monitoring and measurements of outputs, data analysis and product improvement. And this is kind of a striking feature of all of this quality work. The end product includes product improvement, the company takes feedback, monitors everything it does and then uses it to create better products. And this is the essence of the quality management system. So to summarize the QMS means that were intentional about what we do. The roles are formally assigned. The procedures for all tasks are explicitly defined ahead of time and this allows us to follow best practices too hard to organize a company and the project. So in the presence of a proper quality management system, this gives us a handle on what the best way to do this process is. The best way is defined by the consensus of experts in the field, regulators, industry experts and others and if you follow this, you're doing good. The consensus of the field is you're doing things the best way the right way and this is what you want to follow. Whether your product is subject to regulatory approval or not because this will help you optimize your tasks. So continuing on, let's just take a look at the standards here. ISO 9001 is the international standard for Quality management systems. It offers companies a framework to use to ensure quality in the design and manufacture of goods and services and companies can be certified as ISO 9001 compliant. You may see science as you walk around, we arrived at ISO 9001 compliant And the certification here is an ongoing event. You're often audited by registrar often once or two times a year to ensure compliance. Now, medical device companies are certified twice or ISO 13485 but you'll often see All kinds of companies go to this process. Accounting companies, for example, can be either ISO 9001 certified. What is the structure of this document? We'll have the usual preamble and definitions that you see in all international standards, then a discussion of the organization, Leadership planning, support operation evaluation and improvement. Now you would think that recalled the museum will focus on operation and it does. But increasingly the emphasis is shifting to the company itself, the leadership, the planning the support and the bargain evaluation and improvement. All of those things constitute the best practice for running a company. So let's just look at one section of this and we'll compare ISO 9001 and ISO 90003 just to give you a flavor. ISO 9001 says, the organization should determine external internal issues that are relevant to its purpose and strategic direction that affect his ability to achieve the intended results of its quality management system. So this is sort of a generic description for all kinds of companies is something to keep in mind. The organisation shall monitoring reviewing for this information about these external and internal issues. So now if you go to the software standard 90003 it says in part use of cloud application tools and storage. This can be of economic benefit as well as to provide for business continuity but needs research to ensure there is no increased risk organization in using the cloud services providers. So that just guidelines as to how you should approach the use of cloud services as a matter of best practices. The medical device standards for management is size of 1345 and you can actually see the Course sections here. Again, of course, the focus is on product realization but all the other components are there and if you look at ISO 13485 you will get into details that are medical specific things like sterilization will come in into this description. We're not going to go through the standard directly. This is about the last time we mentioned explicitly. Instead, we will focus our discussion in the next two segments on the description of the guidance from the International Medical device regulators Forum. So the reason for this is that this is both specific to software and it's freely available and in every section, the sustainment of the form while the concert present in this section relate to clause four and five in ISO 13 4 85. So in the next couple of segments will work through a description of this QMS to guidance from the MDR. If it has the advantage that it is freely available and this makes it ideal teaching material for students and the specificity and software makes it easier to navigate it without having to say, well this doesn't really apply to softer sterilization. We don't have to worry about it so we'll stop here and in the next two segments will go through this very important guidance document. Thank you
