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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

Goodbye 2020

As we come to the end of 2020, a year that can only be described as stormy, we wanted to send you a quick note of appreciation.  We are grateful for our connection and the opportunity to work together. Thank you for your support, your business, and your resilience in [...]

By |2020-12-01T12:54:12-08:00December 1st, 2020|News, 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

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 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 |2020-05-20T10:56:17-07:00December 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 |2019-11-20T12:15:20-08:00October 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 |2019-09-11T13:32:11-07:00September 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 |2019-06-05T14:20:40-07:00June 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 |2020-06-24T10:24:29-07:00May 10th, 2019|Events, Lean & Agile, News, V&V Testing, V2019, Videos|0 Comments
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