V2018

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

Connected Devices: Cybersecurity & Compliance Summit

Is your medical device secure? I learned a lot about the latest trends in cybersecurity and how to protect medical devices and hospitals at a conference this week hosted in San Francisco and featuring presentations by cybersecurity experts from the medical device industry, from hospital systems, and from vendors of [...]

By |2018-12-13T11:59:18-08:00December 13th, 2018|Events, Medical Device Development, News, V2018|1 Comment

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

FDA Software Guidances and the IEC 62304 Software Standard

“One approach to satisfy two sets of rules” As stated in the last blog post, 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, which is easier to understand, and then [...]

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

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