Many people have great ideas for medical devices that they are sure will revolutionize the surgical suite, and some start a company to develop a product and bring it to market. However, the unfortunate reality is that 9 out of 10 of these startups fail. What are the things that separate successful ventures from [...]
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So far Bill McJames has created 2 blog entries.
In January of this year, the FDA issued its final guidance governing current Good Manufacturing Practice requirements for combination products. The draft guidance was first issued in January of 2015, and the final version includes changes made by FDA that address areas of confusion noted by manufacturers; especially those regarding the “streamlined approach” to [...]