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Noted 2024 Projects

In 2024 I helped 19 clients on multiple projects with their medical device software quality…

How do you hire technical people? This is always a struggle, especially for start-up companies.…

What Documents are Needed to be Compliant with IEC-62304? The European Standard for medical device…

An Electronic Quality Management System (eQMS) is a Software-as-a-Service (SaaS) tool used to fulfill all the…

Rethinking Probability of Occurrence for Medical Device Software Risks: Medical device software – whether it’s…

Agile Methods with MedDev Software Requirements Gathering Lots of people have written about using Agile…

Why Regulations for Medical Device Software? I have yet to meet a software engineer who…

Don’t underestimate the effectiveness of weekly testing, I have an unpopular opinion about software build…

2022 Projects Summary: Last year was a time of growth for me. I added more…

Can ChatGPT Write a Medical Device Software Life-Cycle Process? I used ChatGPT to see if…