Blog 2018-06-02T15:04:25+00:00

Blog

2507, 2017

Keys To A Successful Medical Device Startup

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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 those that don’t make it?  Here are four key elements of a sound business plan for a successful medical device startup. First, make sure your [...]

1007, 2017

Are you up to speed with the cGMP requirements for combination products?

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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 The draft guidance was first issued in January of 2015, and the final version includes changes made by FDA that address areas of confusion noted by manufacturers; especially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 compliance under 21 CFR 4.4(b). The streamlined approach provides that combination product manufacturers may meet the requirements of both the drug cGMPs and device QS [...]