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The European Union has released a sweeping Medical Device Regulation (MDR) that goes into effect for all Medical Devices sold in Europe, next year. This presentation will discuss the unique role of systems engineering in the management of documentation required by the MDR Technical File. We will discuss how to plan a technical file transitions to the MDR, “state of the art” and some new requirements that have a large impact. The MDR expands on ISO-14971 with related requirements for benefit-risk analysis, clinical evaluation, and post market surveillance. Last and certainly not least, we will discuss the issues related to labeling requirements changes.
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Presenter: Lou Wheatcraft
This in-depth, 1-day seminar provides a firm foundation for the definition of the scope for your system of interest. The course presents the student with requirements development best practices that will help your project team develop a winning product—one that delivers what is needed, when it is needed, within the projected costs, and with the expected quality.
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Systems Engineering methods help us produce complex systems. Agile methods help us produce them faster and better. Both together? Awesome. We will explore principles of Systems Engineering from INCOSE and ISO 15288 System Life Cycle Processes, and the principles of Agile scaling methods such as those defined in the Scaled Agile Framework (SAFe®). The topics covered are:
• Lean and Agile Principles Applied to Systems
• Barriers and Benefits to Adopting Agile
• Architecture of Agile Teams, and the roles of
• Defining & Delivering Systems
• Verifying and Validating Systems
• Tailoring Agile Software Practices
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Model-Based Systems Engineering (MBSE) is a hot topic that was first popularized by INCOSE in 2007. It aims to transition development from a document-centric approach to a more formalized approach using models to represent their systems.
In this presentation, Stéphane will introduce Arcadia, a MBSE method dedicated to architectural design, and Capella, the open source modeling workbench that implements the Arcadia method that assists Systems Engineers in managing the complexity of systems architecture and design.
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Requirements management tools have greatly evolved since the days of spreadsheets and text documents. However, even with the most advanced tools, engineers can still inadvertently create conflicting requirements or ambiguous requirements that result in costly re-work and project delays. Artificial Intelligence (AI), supported by Watson, can inject intelligence into the requirements management process, leading to improved outcomes.
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The proliferation of data, resource constraints and internal bias are forcing changes in the way we search for and use IP information. IBM Watson speeds the data understanding, increases the accuracy of the analysis, and increases the number and quality of insights to IP questions for Evidence of Use, Prior Art, Maintenance, Office Actions and Landscaping.
We will discuss the many use cases for applying AI to IP and when in the design cycle this should happen.
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Proliferation of electronic medical records caused a revolution in the previously slow-moving healthcare IT space. Possession of large volumes of patient data and scientific knowledge in medicine leads to new opportunities in analytics - from patient safety to predictive modeling to intelligent management of payment models. Walls between multiple data types in healthcare - life sciences, provider care, medical device engineering - have come down to pave the way for new border-crossing technologies taking advantage of the wealth of data. However, data overload and abundance of computer modeling algorithms pose their challenges. This presentation introduces the audience to this new world of opportunities and challenges for AI in medicine.
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Risk Management considers safety as the primary stakeholder need - a system must function as intended, in its intended environment, safely.
ISO 14971 (and its pending updates!) serve as the de facto standard for the application of risk management to medical devices. Join INCOSE Chicagoland and SME, Mike Gut to learn about the requirements for risk management and how they determine the safety of a medical device by the manufacturer during a product's life cycle.
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