Sciessent Medical Blog

Everything You Ever Wanted to Know about the FDA’s 510(k) Submission … But Were Too Afraid to Ask (Part Three)

Posted by Administrator

We’ve come to the end of our blog series about best practices for the FDA’s 510(k) submission process for antimicrobials. We discussed the importance of defining the indications of use, choosing predicate devices and defining antimicrobial chemistry and mechanism of action. Today, we’ll look at ...

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Topics: 510(k), medical device, HAIs, healthcare

Everything You Ever Wanted to Know about the FDA’s 510(k) Submission … But Were Too Afraid to Ask (Part Two)

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Topics: Antimicrobials, 510(k), HAIs, medical devices

Everything You Ever Wanted to Know about the FDA’s 510(k) Submission … But Were Too Afraid to Ask (Part One)

Posted by Administrator

At Sciessent, we work heavily within the healthcare space – helping manufacturers bring their antimicrobial-treated devices to market. Not only do we provide the antimicrobial technologies, but we’re also very involved throughout the lifecycle of the product – from design, development and testing ...

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Topics: Antimicrobials, 510(k), medical devices, healthcare

The Art of Incorporating Antimicrobials Into Med Devices – Part Two

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While we discussed three of the four challenges/best practices for incorporating antimicrobials onto the surfaces of medical devices in our last post, we left the last and perhaps most complex topic for its own blog. This is the wild world of regulatory approval.

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Topics: Antimicrobials, 510(k), medical device, HAIs

The Art of Incorporating Antimicrobials Into Med Devices – Part One

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Topics: Antimicrobials, 510(k), HAIs, medical devices