510(K) Success!
RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to...
View ArticleRegulatory Intelligence
How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig...
View ArticleMobile Medical Applications: Make Sure uChek with FDA
The latest mobile medical application news on the industry’s collective mind is the issuance of an “It has come to our attention…” letter sent to Biosense Technologies in India, essentially questioning...
View ArticleMobile Medical Applications – Most Reliable Apps, Internationally?
A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share! 1.) Verizon Wireless – “America’s largest and most reliable network” –...
View ArticleFDA gives Voice to the People
The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making...
View ArticleFirst Artificial Pancreas receives FDA Approval
Upon my nightly adventures of surfing the World Wide Web I came across this article on the Popular Science website announcing the FDA’s approval of the Medtronic MiniMed 530G Insulin pump, praisingly...
View Article510(k) Pop Quiz!
How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got...
View ArticlePediatric Subpopulations – Final Rule
On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that...
View ArticleGuidance Documents for 2014
In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can...
View ArticlePre-Submission Program – Final Guidance
On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA...
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