RQM+ Medical Device and In Vitro Diagnostic Blog

on 14 November 2017 | By Stephen Biernacki

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients. Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve...

on 21 September 2016 | By Stephen Biernacki

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark! Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing...

on 21 June 2016 | By Stephen Biernacki

What an action-packed three days MD&M East was this year! Our team is exhausted, but in the absolute best way possible. I'm not sure how anyone who attended the show could've escaped the exhaustion... as the exhibit floor was BIG. If you're reading this and attended, hopefullly...

on 17 June 2016 | By Kate Keverline

Everyone appreciates a good night's sleep. A big obstacle to that is the fact that 18 million American adults suffer from Obstructive Sleep Apnea (OSA), and the condition arises simply from a wayward throat muscle. A new study by Dr. Richard Schwab, co-medical director of the...

on 26 January 2016 | By Stephen Biernacki

Behold medical device ingenuity at its finest. In 2013 the NewYork-Presbyterian Morgan Stanley Children's Hospital purchased a pirate-themed CT scanner, and the result is an incredible way to put children at ease before being scanned. See the rest of the creativity in pictures...

on 6 January 2016 | By Stephen Biernacki

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.

on 1 December 2015 | By Stephen Biernacki

One of R&Q's priorities in 2015 was to find new, distinctive ways to tell our story. We wanted to make it abundantly clear to potential clients and employees that R&Q is first and foremost about improving lives. We also wanted to clearly explain how we improve lives. The result...

on 20 December 2013 | By Ryan Kasun

This past weekend I travelled to the Chicago-land area to attend my brother’s graduation from Northern Illinois University and commissioning into the US Army. He will be reporting to Fort Leonard Wood, Missouri for officer training as part of the Army Corps of Engineers. This...

on 18 October 2013 | By Ryan Kasun

The standard treatment for patients with cancer of the larynx is to have a tracheostomy tube installed. Tracheostomy tubes are Class II devices, under 21 CFR 868.5800. According to ProTip CEO Maurice Beranger, this technology has not changed in 140 years. Tracheostomy tubes...

on 1 October 2013 | By Ryan Kasun

Earlier this year I joined a running club, Steel City Road Runners (come run with us!). I’m still a newbie, but I really enjoy the challenge that running provides. This past week, the Boston Marathon announced to applicants who would be awarded the last 5,000 spots in the 2014...

on 22 August 2013 | By Ryan Kasun

Every once in a while, when I’m not running, I like to take my bike down to the river trails of downtown Pittsburgh. I throw my bike rack on my car, strap it in, and I’m ready to go. Being as I only used my bike rack about ten times since I got it, I was surprised when I went to...

on 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...

on 25 April 2013 | By Ryan Kasun

FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1...

on 24 April 2013 | By Ryan Kasun

Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!

on 16 April 2013 | By Ryan Kasun

Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked...

on 3 April 2013 | By Ryan Kasun

As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to...

on 26 March 2013 | By Ryan Kasun

The season is upon us. Unfortunately, the season is not spring…winter still seems to be lingering. However, the season of March Madness is in full swing! Everyone’s bracket selections are in, and we wait to find out who is the National Champion.

on 22 March 2013 | By Ryan Kasun

Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA...

on 20 March 2013 | By Ryan Kasun

Last week I had the opportunity to attend the Human Factors & Ergonomics Society Health Care Symposium. Since I work on medical devices, I mainly went to the presentations in the medical devices track and found them to be very interesting and educational. The opening keynote...

on 14 March 2013 | By Ryan Kasun

My son has a friend that was born deaf. When he was a small child, he had surgery to get cochlear implants. With the implants, he is able to hear. When his younger brother was also born deaf, his parents found that they carried a recessive gene that causes deafness. Both boys...

on 5 March 2013 | By Ryan Kasun

In the medical device field the name of the game is Compliance. The reason for V&V testing is compliance. Prior to distribution you need to provide evidence of compliance. Everywhere you turn there are rules where the medical device manufacturer or distributor must provide...

on 26 February 2013 | By Ryan Kasun

I heard an interesting new term today (new to me at least!) that I thought greatly impacts the line of work I am in. Regulatory science is "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated...

on 19 February 2013 | By Ryan Kasun

Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality...

on 8 February 2013 | By Ryan Kasun

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange...

on 5 February 2013 | By Ryan Kasun

Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium - the automated compliance robot!

on 25 January 2013 | By Ryan Kasun

My mom works as an x-ray technician at a small orthopedic office in Chicago-land. Recently, the office ordered a new x-ray machine to replace their old and outdated equipment. My mom was very eager to use the new equipment, and was very happy to have an upgrade. However, after a...

on 21 January 2013 | By Ryan Kasun

I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the...

on 21 January 2013 | By Ryan Kasun

Wrap-up of a few notable news stories from last week:

on 10 January 2013 | By Ryan Kasun

January is usually that time of year where I start day dreaming about a vacation somewhere warm and sunny. California is always on the list. California has a lot more to offer than just its beautiful beaches and amazing sights. A recent article on the biomedical industry had...

on 27 December 2012 | By Ryan Kasun

Have you ever received a gift that you didn’t really want? Was it an ugly sweater from Great Aunt Margie, or a holiday pillow that didn’t quite match with your décor? People always say, it’s the thought that counts… but if that was the case, gift receipts would not be so...

on 18 December 2012 | By Ryan Kasun

In recent years, my father has picked up a new hobby of star-gazing. What started out, as I believe, as an excuse to get out of the house and away from the mother-in-law, has slowly turned into a full-fledged astronomical geekfest (no pun intended). So, for Christmas this year,...

on 12 December 2012 | By Ryan Kasun

I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device...

on 10 December 2012 | By Ryan Kasun

In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:

on 4 December 2012 | By Ryan Kasun

Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the...

on 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...

on 14 November 2012 | By Ryan Kasun

Several years ago a good friend who knows my interest in human factors and engineering psychology gave me a book called Set Phasers on Stun and Other True Tales of Design, Technology, and Human Error, by Steven Casey. I started to read it again recently and wanted to share it...

on 2 November 2012 | By Ryan Kasun

Trick-or-treating in my neighborhood was moved to Saturday this year because of Hurricane Sandy...therefore I needed a few Halloween jokes to keep me going until this weekend. Here you go:

on 19 October 2012 | By Ryan Kasun

A good friend of mine in high-school was trying to understand the definition of a "hyperbole". Now, if Google would have been sophisticated enough at the time to include the "define:" feature, it would have returned the following for hyperbole: Exaggerated statements or claims...

on 19 October 2012 | By Ryan Kasun

Every time I go home to visit my parents, one thing that comes up more often than not, is the fact that our local Blockbuster closed. It’s been about two years now, and they still can’t get over it. Me? I’m happy to rent from a RedBox, or even better, kick my feet back on the...

on 11 October 2012 | By Ryan Kasun

On Tuesday, I attended a Pittsburgh Technology Council event downtown titled “Medical Devices and the European Union: What does the Path of Entry Look Like?” which was sponsored by RQS! (We gave out stress balls in the shape of a pill!) I’ve posted a few times before regarding...

on 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.

on 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...

on 1 October 2012 | By Ryan Kasun

Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a...

on 28 September 2012 | By Ryan Kasun

Eureka! A light bulb goes off, and suddenly you’ve invented a great new medical device that will save millions of lives worldwide every year.

on 14 September 2012 | By Ryan Kasun

What???

on 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...