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

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

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

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

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 |2018-12-14T10:08:33-08:00December 14th, 2018|Events, News, Newsletters, V2018, Videos|0 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

Newsletter V. 2018 Issue 1

Beginner’s Guide to Medical Device Software “Medical Device Software for Newbies” or “Why is this stuff so confusing?” This article is designed for people who are new to medical device software—either experienced with software but not medical device regulations or experienced with medical device hardware only. Why is software special? [...]

By |2018-09-05T10:22:29-07:00February 13th, 2018|News, Newsletters, V2018|0 Comments