on 22 May 2024 | By Erin Gontang, Senior Consultant, RQM+
The FDA's recently proposed rule on wound care products has sent ripples through MedTech. This rule, if finalized, could significantly impact the classification, labeling, and testing requirements for a wide range of wound care devices.
Read Moreon 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 14 October 2016 | By Kate Keverline
Within driving distance to D.C.? There's still time to enjoy a few days there next week and simultaneously hone your submissions skills. The FDA, R&Q, and other talented industry experts courtesy of AdvaMed are offering three workshops dedicated to teaching you the guidelines...
Read Moreon 24 August 2016 | By Nancy Morrison, RQM+
It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, 2016 it finally happened! For those of you who remember the FDA's attempt...
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 21 February 2014 | By Ryan Kasun
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 prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de...
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 5 September 2013 | By Stephen Biernacki
In the FDA-regulated medical device world, there are 3 classifications for medical devices: Class I, Class II and Class III. The FDA (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm) provides a rather in-depth overview of how...
Read Moreon 3 June 2013 | By Ryan Kasun
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 obtain clearance, but swell with pride because of how we obtained it.
Read Moreon 29 May 2013 | By Ryan Kasun
The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about...
Read Moreon 28 March 2013 | By Ryan Kasun
Last week I saw several articles published about a new device that is going to shake up the Craniomaxillofacial device market, and the Orthopedic market is next on the list. 3D Printing – chances are you’ve just started hearing about it, mostly concerning gun controls laws for...
Read Moreon 7 February 2013 | By Ryan Kasun
The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My...
Read Moreon 28 January 2013 | By Ryan Kasun
With the recent announcement of 510(k) clearance of a retinal examining attachment and companion app can we now declare the outcry against the FDA finished?
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...
Read Moreon 13 December 2012 | By Ryan Kasun
I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something...
Read Moreon 6 December 2012 | By Ryan Kasun
Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.
Read Moreon 30 November 2012 | By Ryan Kasun
In a fantastic case of science-fiction-meets-reality, Qualcomm created the X Prize Foundation to challenge developers and innovators to create a Star Trek Tricorder. The prize? $10M!
Read Moreon 29 November 2012 | By Ryan Kasun
Thanksgiving night I was standing outside in the cold in a line that wrapped halfway around Target. My motivation for this spontaneous Black Friday door-buster shopping was peer pressure, but I was also excited to take advantage of the great prices. Even though I wasn't in the...
Read Moreon 15 November 2012 | By Ryan Kasun
I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office...
Read Moreon 5 October 2012 | By Ryan Kasun
Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.
Read Moreon 3 October 2012 | By Ryan Kasun
Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or...
Read Moreon 18 January 2012 | By Ryan Kasun
After a small hiatus, the Mobile Medical Apps blog series is back! Today we'll take a look into wellness and weight-loss applications.
Read Moreon 2 December 2011 | By Ryan Kasun
Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on said iPad (both versions 1 and 2 according to...
Read Moreon 28 November 2011 | By Ryan Kasun
As with all software and technology, security is, and will always remain, a hot-button topic. It is even a point of contention for computer consumers - Mac vs. PC debates often will focus on how Mac's don't "need" virus protection (which is somewhat of a misnomer, but certainly...
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