Improving medical device software development isn’t just about adding or modifying. The simplest approach is to NOT do things that don’t need doing. This is a key theme we cover in our training and consulting. “Faster, better, cheaper” is easier to attain when you do less and reduce complexity. The same applies to safety and...Read More

Developing safe and effective medical device software is not easy. Doing that efficiently AND meeting regulatory compliance requirements is even harder. Many companies are implementing agile or lean software development methods to improve results. But can those methods also be compliant at the same time? Yes! There is a caveat, however … agile approaches “out...Read More

The Agile & Compliant February courses have early registration discount deadlines are coming up soon: Americas: 14 January 2025 EU et al: 21 January 2025 Pacific: 28 January 2025 Full details and registration form at https://www.softwarecpr.com/2024/12/1st-quarter-2025-agile-compliant-courses-scheduled/Read More

I got a cancellation notice today for my driver’s license renewal appointment. Reason? “Internet down statewide and will not be resolved today.” The outage was actually worldwide. You probably saw news reports or were affected by it. A software update by cybersecurity firm Crowdstrike caused some Windows systems to stop working. Outages didn’t just affect...Read More

I (Mike Russell) attended the neXus conference on medical device standards this year. Below are some observations and suggested takeaways from the talks I heard and the panel I was on. Remember, these are just selected highlights, not everything said 🙂 Session: Reducing Submission Rejections and Recalls with Software Standards This year’s conference added a third...Read More

By Ron Baerg and Mike Russell “You can pay me now, or you can pay me later” was the punch line of a memorable TV commercial by the FRAM® company about their oil filters around 50 years ago. The “me”: a car mechanic. Their point: paying (a little) now to replace your oil filter regularly...Read More

Compliance and Agile In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors. Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider...Read More

“Agile” remains a hot topic in general, and “compliant agile” is a goal in many medical (and other regulated) companies. However, “agile” also remains difficult and elusive for many. This article will examine one of the most common hurdles to achieving agile benefits from well-intentioned initiatives. First, let’s address agile and medical device development in...Read More