Agile methods are appearing more and more in regulated health-related applications. The teams carrying out this development must work both rapidly and flexibly, since they are obligated to satisfy not only their business management, but also the patients and caregivers, and, of course, the regulatory bodies who must approve their products. Teams must document all aspects of their development - requirements, design, tests, hazard analysis, usability, and traceability. How do we achieve all that and remain Agile? Many companies struggle with meeting all these expectations; software-related product recalls and failed companies are the legacy of traditional, sequential methods. How can we gather these as development proceeds, while minimizing overhead? How can we assure that inputs are reviewed and approved, without getting mired in the document signoff spiral? How can we address design reviews without bogging down the team in long, droning meetings? How can we capture traceability as a natural outcome of our work? Experience is showing, and the AAMI Agile report (TIR 45) has stated, that when Agile is properly applied in the context of a quality system and robust safety risk management, its emphasis on nimbleness and ongoing learning can be reconciled with regulatory expectations of well-documented development. For more information and to register, click here.
Medical device development struggles with huge pressures: the need for innovation, keeping cost down, and minimizing time to market. With all its success in other industries, it appears that the Agile approach be a huge should help – but even after years of use and multiple reports, criticism of, and doubts about, Agile methods exist in the medical device field. Would an Agile team address safety and regulatory demands? How will the company plan its work if development is incremental? Will software teams be able to interact with other disciplines where timelines are longer? How would Agile work when teams are larger or working in multiple locations? This webinar will outline key fundamentals of Agile and address issues which inevitably arise in adopting an Agile approach – with the intention of alerting managers to the items they will need to consider in their own Agile adoption program. For more information and to register, click here.
25-26-27 October 2017 Euskalduna Conference Center, Bilbao, Spain
It’s our intention to diffuse the latest technological developments in Software Testing and Quality Assurance, and to showcase successful best practices, which may give you a lead in Global Competition. The success of the last editions prove that our formula is flourishing. QA&TEST® is a unique conference which brings together professionals and experts from different sectors such as: Railways, Aeronautics, Medical Systems, Electronic Devices, Banking, Insurance and Telecommunications. QA&TEST® is for decision-makers such as Directors, Program Managers, Project Managers, as well as Testing Professionals who work in the field of the Software Quality and Testing. Because all of this we are proud to say that QA&TEST® is the most important international conference about testing technology, testing systems and testing methodology that will be held in Spain. We hope to give you a warm welcome in October.
Presentation: Agile for Safety-Critical and Regulatory-Bound Products (Agile where you can kill someone) Many organizations that provide regulated, high-assurance, safety-critical software and hardware development struggle with Agile. High-assurance products are ones that may risk human life and health. Product development challenges include audits, regulatory documentation, risk management, safety, security, and traceability. Based on experience using Agile with medical device software and hardware, you learn how to initiate and maintain Agile practices for these types of systems. This presentation will show how tools like story and impact mapping are integrated into product development; it will explain how to use safety stories, integrate traceability using your story map, and specify tests to address safety and hazard mitigation requirements. It will demonstrate how to conduct incremental hazard analysis and mitigation and formal design review to satisfy regulatory requirements - and it will explain how stakeholders — including marketing, engineering, and service — can share a coherent vision early in development to support the special demands of the high assurance products. This presentation is relevant to all types of high-assurance software and hardware development projects. You will see how you can use a lean process to develop these types of products, which are so important for health and safety in modern life. Using actual medical device examples, you will learn how to create thin vertical slices of organizational activity to deliver fully compliant, high quality, high assurance, customer value on time.