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Validation of Off-The-Shelf Software Development Tools

A reader asked me about OTS software tool validation. He says: It seems to me that the editor and any other tool used to create the software is exactly that, a productivity tool. The end result...

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Building Safety into Medical Device Software

The article Build and Validate Safety in Medical Device Software takes a critical look at the current processes for medical device software and concludes: The complexity of the software employed in...

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OTS/SOUP Software Validation Strategies

My last discussion of Off-The-Shelf software validation only considered the high-level regulatory requirements.  What I want to do now is dig deeper into the strategies for answering question #5: How...

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When Open-source can Kill or Cure

The use of open-source software in medical devices has been a topic of discussion for many years. The Economist article Open-source medical devices: When code can kill or cure highlights continuing...

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Medical Device Innovation Consortium

The FDA has announced the Medical Device Innovation Consortium (MDIC)  which aims to help medical device companies get their products to market faster. See FDA, Private Groups Team Up to Speed Device...

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Interoperability: Arrested Progress

When it comes to the state of interoperability in the medical device industry there couldn’t be a better metaphor than Arrested Development*.  A dysfunctional family made up of eccentric well-meaning...

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FDA Recognition of Medical Device Standards for Interoperability

This is a follow-up to Interoperability: Arrested Progress. The FDA has recognized voluntary interoperability standards for medical devices: Improving Patient Care by Making Sure Devices Work Well...

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FDA Regulation of Mobile Medical Apps

The FDA has issued their final guidance on mobile medical applications: Keeping Up with Progress in Mobile Medical Apps. The guidance document (PDF) will “give mobile app creators a clear and...

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FDASIA Health IT Report

The Food and Drug Administration Safety and Innovation Act (FDASIA) required the FDA to develop: a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory...

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Software Doesn’t Have An MD

I got a kick out of this Andreessen Horowitz piece: Digital Health/SOFTWARE DOESN’T HAVE AN MD. I’m sure ‘the kid in the garage without a degree’ is no dummy, but this premise: And so that large...

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