News

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 [...]

By | 2019-12-04T15:18:06-08:00 December 3rd, 2019|News, Newsletters, V2019|0 Comments

Invaluable for the team’s success

Aaron is excellent to work with and has been invaluable for the team’s success. His consistently identified issues and provided recommendations for resolving technical, process and regulatory challenges. Aaron is technically competent and is able to lead a cross functional group to resolution. Aaron is who I would call on [...]

By | 2019-11-20T12:15:20-08:00 October 9th, 2019|News, Regulatory Compliance, V2019|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 | 2019-09-11T13:32:11-07:00 September 11th, 2019|Events, News, Newsletters, V2019|0 Comments

Newsletter V. 2019 Issue 2

Have employees new to medical devices? I offer practical training on Medical Device Design Controls either on site or at a public workshop. Contact me Agile Design Controls This is a three part recorded webinar series that illustrates a flexible and rigorous approach to managing design controls for software-intensive medical [...]

By | 2019-06-05T14:20:40-07:00 June 5th, 2019|News, Newsletters, V&V Testing, 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 | 2019-06-05T13:37:37-07:00 May 10th, 2019|Events, Lean & Agile, News, V&V Testing, V2019, Videos|0 Comments

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

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 | 2019-04-02T18:49:52-07:00 February 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 | 2019-06-05T13:42:32-07:00 February 18th, 2019|Events, Lean & Agile, News, V2019, Videos|4 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 | 2018-12-14T10:08:33-08:00 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 | 2018-12-13T11:59:18-08:00 December 13th, 2018|Events, Medical Device Development, News, V2018|1 Comment