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.
Month: June 2020
Does blockchain have a role in transforming healthcare? The focus of this article is to offer a few objective thoughts about this question as well as to provide a few use cases for which blockchain might be used in healthcare
Internships are a very interesting part of the college education experience. While they are not mandatory, I was told that they are the key to success for one’s future career. Hearing that two years ago, as an incoming freshman, definitely put some stress onto my shoulders.
The medical industry has a wide array of applications for image acquisition and processing. While the most common types are X-ray, MRI, and ultrasound images, applications can benefit patients in lesser-known areas, as well. From early tooth decay detection, to cell identification using microscopy images, medical device image processing is a vital part of quality healthcare.
Recently I took on a part-time position as a mentor for code camp students. The mentoring is performed 100% remotely and takes me 5-6 hours per week. This fairly small investment of time has yielded me a wealth of experience and learning opportunities.
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.
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.
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.
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.
The third edition of risk management process standard ISO 14971 is now available. This blog post summarizes the changes in the new edition of the standard and discusses what the changes mean to medical device development professionals.