About tshafer

This author has not yet filled in any details.
So far tshafer has created 14 blog entries.

Newsletter V. 2021 Issue 1

April 2021 Newsletter - Better Approach to Medical Device Development  Let’s Get Back to Basics   Medical device development is often discussed in terms of adhering to new regulations or standards. While the complexities of good compliance are certainly important, it’s easy for teams to overlook the basics of what’s needed [...]

By |2021-04-07T08:59:04-07:00April 5th, 2021|News, Newsletters, V2020|0 Comments

Newsletter V. 2020 Issue 2

OCT 2020 Newsletter - Medical software challenges and new digital opportunities Some of the most promising innovations in healthcare technology today are based on software development and the digital health sector itself is a large and growing part of the industry (see below).  Software enables many new opportunities in healthcare [...]

By |2020-10-21T12:31:19-07:00October 21st, 2020|News, Newsletters, V2020|0 Comments

Newsletter V. 2020 Issue 1

The world as we know it is changing. Covid-19 has created huge disruptions and it’s harder than ever for teams to effectively communicate and develop new medical devices. Business collaboration and decision making are increasingly difficult. Fortunately plenty of organizations and companies are broadcasting new tools for collaboration. Maybe you’ve [...]

By |2020-05-20T16:16:37-07:00May 20th, 2020|News, Newsletters, V2020|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 |2019-11-20T12:15:20-08:00October 9th, 2019|News, Regulatory Compliance, 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 |2019-06-05T14:20:40-07:00June 5th, 2019|News, Newsletters, V&V Testing, 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 [...]

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 |2019-03-20T07:13:18-07:00March 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 |2020-11-11T08:12:32-08:00February 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
Go to Top