Documentation for Medical Device Software
The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
Quality Systems
How to set up a quality system for a medical startup
(or “achieving compliance without bringing everything to a crawl”) Creating a quality system is fundamental for a medical startup because 1) it’s the law, and 2) it ensures a safe, reliable product. While a good quality system encompasses best practices at a company and makes the most of each employee’s work, a bad one hinders …
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