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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. Why connected devices are different? Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices Learn the nuts and bolts [...]

By | 2019-03-20T07:13:18-07:00 March 20th, 2019|News, Newsletters, Software Development, V2019|0 Comments

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 [...]

By | 2019-03-18T13:55:48-07:00 March 18th, 2019|Software Development, V2019|0 Comments

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 management SW tool to create a more flexible [...]

By | 2019-03-18T14:05:03-07:00 February 18th, 2019|Events, Lean & Agile, News, V2019|0 Comments

Webinar: Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices

https://vimeo.com/317634638 Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices How to examples using Matrix ALM and JIRA Traditional methods for medical device development cannot keep up with the challenges of modern, software-intensive medical devices, which need to be developed iteratively and to be regularly updated [...]

By | 2019-02-28T12:51:56-07:00 February 18th, 2019|Events, Lean & Agile, News, V2019, Videos|0 Comments

Agile Design Controls: How to Support Rapid Design Iterations for SW-Intensive Medical Devices

How to examples using Matrix ALM and JIRA Traditional methods for medical device development cannot keep up with the challenges of modern, software-intensive medical devices, which need to be developed iteratively and to be regularly updated after launch.  Software tools for requirements management, test management, and defect tracking allow product [...]

By | 2019-02-07T08:32:21-07:00 January 23rd, 2019|Events, Lean & Agile, V2019|0 Comments

Newsletter V. 2018 Issue 3

My Notes on CyberSecurity I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at the Connected Devices: CyperSecurity & Compliance conference this week hosted in San Francisco. Here are my notes from the conference Upcoming Events Agile Design Controls: How to [...]

By | 2018-12-14T10:08:33-07:00 December 14th, 2018|Events, News, Newsletters, V2018, Videos|0 Comments

Connected Devices: Cybersecurity & Compliance Summit

Is your medical device secure? I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at a conference this week hosted in San Francisco and featuring presentations by cybersecurity experts from the medical device industry, from hospital systems, and from vendors of [...]

By | 2018-12-13T11:59:18-07:00 December 13th, 2018|Events, Medical Device Development, News, V2018|1 Comment

Newsletter V. 2018 Issue 2

FDA Software Guidances and the IEC 62304 Software Standard There are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard and then include any additional adjustments needed to meet all the FDA requirements. [...]

By | 2018-12-04T09:29:01-07:00 September 5th, 2018|News, Newsletters, V2018|0 Comments

FDA Software Guidances and the IEC 62304 Software Standard

“One approach to satisfy two sets of rules” As stated in the last blog post, there are two sets of rules for SW regulation—twice the rules, twice the confusion. My recommendation is to base your software development procedures on the IEC 62304 Standard, which is easier to understand, and then [...]