Blog

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 | 2020-02-07T18:04:19-08:00 February 7th, 2020|Uncategorized|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 | 2019-12-04T15:18:06-08:00 December 3rd, 2019|News, Newsletters, V2019|0 Comments

How to set up a quality system for a medical startup

(or “achieving compliance without bringing everything to a crawl”) Creating a quality system is fundamental for a medical startup because 1) it’s the law, and 2) it ensures a safe, reliable product. While a good quality system encompasses best practices at a company and makes the most of each employee’s [...]

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

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 | 2019-04-08T09:50:48-07:00 April 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 [...]