Events

Looking forward to presenting at MD&M with Roger Tang

The Two Mindsets of Successful Medical Device Development Modern product development teams face increasing challenges in bringing new medical devices to market: greater product complexity, tighter budgets, and more regulatory scrutiny. Agile and Lean practices, properly implemented, can enable medical device companies to accelerate product development, improve product quality, and [...]

By |2020-05-20T10:18:23-07:00February 7th, 2020|Events, News, V2020|0 Comments

Newsletter V. 2019 Issue 3

Risk Management Risk management plays a central role in medical device development but many medical device professionals I’ve worked with over the years seem to have missed the forest for the trees.  They are more focused on the details of risk management compliance than the central goal of product safety. [...]

By |2019-09-11T13:32:11-07:00September 11th, 2019|Events, News, Newsletters, V2019|0 Comments

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

https://vimeo.com/333499493 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 [...]

By |2020-06-24T10:24:29-07:00May 10th, 2019|Events, Lean & Agile, News, V&V Testing, V2019, Videos|0 Comments

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

April 30, 2019 at 9am PST (5pm CET) 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 [...]

By |2019-04-08T09:50:48-07:00April 8th, 2019|Events, Lean & Agile, V2019|0 Comments

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

https://vimeo.com/326954860 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 [...]

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 |2019-04-02T18:49:52-07:00February 18th, 2019|Events, Lean & Agile, News, V2019|1 Comment

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 |2019-06-05T13:42:32-07:00February 18th, 2019|Events, Lean & Agile, News, V2019, Videos|4 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 |2019-02-07T08:32:21-08:00January 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 |2018-12-14T10:08:33-08:00December 14th, 2018|Events, News, Newsletters, V2018, Videos|0 Comments