4 top regulatory issues to watch in 2017
This is shaping up to be a big year when it comes to medtech regulation, as well as regulations for other types of life science companies.
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FDA Proposes Ban on Powdered Gloves After Years of Review
In a rare move, FDA has proposed banning most types of powdered medical gloves in the United States. Some say the decision took too long.
What You Need to Know: IEC 60601-1-2 4th Edition
An expert discusses what medical device manufacturers need to keep in mind as the compliance date for the fourth edition of the IEC 60601-1-2 standard approaches.
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510(k) Tips for Antimicrobial-Treated Devices
Manufacturers should familiarize themselves with seven important FDA requirements for 510(k) submissions for these products.
2016 FDA Guidance Documents You Should Know
These were the most important guidance documents of the year for medical device manufacturers.
4 Tips for a Smooth 510(k) Submission Process
As you are probably aware, a 510(k) submission is required in order to get FDA market clearance for nearly all Class II devices.
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