on 25 January 2017 | By Stephen Biernacki
About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this...
Read Moreon 2 February 2016 | By Stephen Biernacki
Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other industry experts at AdvaMed's 510(k) Submissions Strategy Workshop in Irvine, CA this month. The event is scheduled for two days: February 22-23. Marilyn is R&Q's Senior Principal Advisor and Nancy is...
Read Moreon 10 January 2014 | By Ryan Kasun
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 right!
Read Moreon 14 January 2013 | By Ryan Kasun
There has been much controversy about the new RTA FDA Guidance document titled "Refuse to Accept Policy for 510(k)s". The draft of this guidance was issued for review in August of 2012 and was recently released at the end of that year. However companies are still talking about...
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