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Go West Young Man

I’ve never lived outside of Indiana before and had only visited San Diego twice, but when I heard the plans for a West coast office, I was terrified! But the more I thought about it, the better it sounded. I was still (relatively) young, no wife or children to transplant, and it felt like the kind of shake up I needed.

Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD)

The FDA has released a discussion guideline and request for feedback regarding changes in the certification process for medical device software that uses artificial intelligence and/or machine learning – see https://www.fda.gov/media/122535/download. This blog post explores what this FDA document means to companies who are involved in writing medical device software.

Validating Cloud Software Tools

The FDA “General Principles of Software Validation” was written in 2002 – well before the era of pervasive use of cloud computing. However, this FDA document was written in such a way that it can be applied to use of cloud computing tools that are part of a medical device or that are used in the development of medical device. This blog post explores approaches to validating cloud computing tools.

Creating a LIS Middleware Server for Linux

The RND Group created a custom solution for one of our clients that integrates the instrument software with Laboratory Information Systems (LIS). The solution we developed for our client improves productivity, reduces clinical errors, and is part of the client’s FDA medical device software solution. In this blog we outline the challenges faced and how we achieved success.

Are You IEC 63204 Compliant?

Developing IEC 62304 compliant software isn’t trivial. With this, you must develop software that supports its intended use, while also complying with ISO 13485, ISO 14971, and IEC 62304 international standards. Then, if you include GDPR in the mix, you can easily get lost and overwhelmed – unless you leave it up to an expert. IEC 62304 is the gold standard for medical device software, but its importance goes far beyond ensuring regulatory compliant manufacturing and software development. Let’s start from the beginning.

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