tshafer

About tshafer

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So far tshafer has created 12 blog entries.

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 |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

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 |2018-12-04T09:29:01-08:00September 5th, 2018|News, Newsletters, V2018|0 Comments

On-time and under budget

Aaron Joseph helped Luma Therapeutics develop our quality system procedures and DHF documentation for the Luma Light System in 2017. This was in preparation for an FDA 510k filing. He came in on time and under budget for his services and was a valuable addition to the team. He has [...]

By |2019-11-20T12:18:47-08:00January 20th, 2018|News, Testimonials, V2018|0 Comments