R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Crowd Source in Medical Devices?

Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known example), but other examples are appearing more frequently, including in the medical device industry.

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.

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