V2019

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Newsletter V. 2019 Issue 4

Medical Device Startups Startups are the heart and blood of the medical device industry. They are driving innovation and making healthcare more effective and more personalized. Because of this, startups are well positioned for an emerging ecosystem of interconnected medical technology and services.  Investors see the enormous opportunities in improving healthcare and developing technology and …

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Flowchart of risk management processes

The Big Picture for Medical Device Risk Management

Understanding all the details of risk analysis methods and compliance with the ISO 14971 risk management standard can be quite complicated but fundamentally, for development of a new medical device, risk management is about answering these seven key questions: What are all the possible things that could go wrong?  What are we most worried about?  …

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Agile Design Controls V&V

Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices

This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of requirements with multiple retesting and with automatic …

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AgileDesignControlWebinar1904

Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices

Available Now This webinar describes how to support rapid design iterations of medical devices while still maintaining systematic, rigorous V&V testing. Traditional approaches to V&V are often slow, inefficient, and break down with repeated testing. Learn how to configure modern SW tools to manage testing of a large number of requirements with multiple retesting and …

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Agile Design Controls Part2

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices

Agile Design Controls Part 2 Webinar: Dynamic Risk Management for SW-Intensive Medical Devices This webinar describes a dynamic approach to managing risk analysis and risk controls to keep up with fast moving product development teams.  Learn the nuts and bolts of how to integrate risk management into the overall product development workflow using a requirements …

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Newsletter V. 2019 Issue 1

Embracing Change: Your Connected Medical Device is Never Finished Embracing change means setting up your organization, processes, and tools to efficiently manage changes during product development and after product launch. Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices Learn the nuts and bolts of how to integrate risk management into the overall product …

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Connected Medical

Embracing Change: Your Connected Medical Device is Never Finished

The proliferation of software in modern medical devices has enabled innovative new applications and many benefits to patients.  However, it has also created greater challenges for medical device companies: namely, managing greater product complexity and more reliance on third party software components.  For connected devices there are the added challenges of cybersecurity risks, protecting patient …

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