on 17 April 2020 | By Deven Snyder
This post is an update to our recent blog post where Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shared her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline. You can read that post here.
Read Moreon 13 April 2020 | By Deven Snyder
Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. In China alone, where the virus was first detected, many medical device companies have manufacturing sites, utilize...
Read Moreon 19 March 2020 | By Deven Snyder
Nancy Morrison, R&Q's Executive Director, Regulatory & Quality Consulting Services, shares her thoughts on the potential impact of the COVID-19 pandemic on the EU MDR timeline: Team NB, the European Association of Notified Bodies (NB) that are active in the medical device...
Read Moreon 18 March 2020 | By Deven Snyder
As most of the world seems to be at a standstill this week, the European Commission published new guidance (MDCG 2020-3) to further define “significant change” requirements under the new Medical Device Regulation (MDR) policies coming our way on May 26, 2020. The highly...
Read Moreon 24 February 2020 | By Deven Snyder
Check out R&Q experts' European Union Medical Device Regulation (MDR) 2017/745 Health Check List below to determine the areas to focus your resources in the final few months before the May 26, 2020 MDR Date of Application. If you have questions, concerns, or need any help...
Read Moreon 31 January 2020 | By Deven Snyder
After four years, many heated debates, several delays, and a few Prime Ministers later, the United Kingdom (U.K.) is officially leaving the European Union (EU) today, January 31, 2020. Well, sort of. Instead of the “hard Brexit” that had been promised and feared in March, April,...
Read Moreon 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...
Read Moreon 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...
Read Moreon 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...
Read Moreon 7 February 2013 | By Ryan Kasun
You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming....
Read Moreon 20 December 2012 | By Ryan Kasun
As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I have heard my fair share of “Mistake on the Lake (Erie)” jokes. Yes, it’s true the Cuyahoga River caught fire in 1969, the city has suffered from loss of jobs due to de-industrialization, there have...
Read Moreon 17 December 2012 | By Ryan Kasun
During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
Read Moreon 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...
Read Moreon 11 December 2012 | By Ryan Kasun
My teenager works at a local eatery – I thoroughly believe the saying, “A good teenager is a tired teenager”. Besides, there is a lot to be learned from being in the work force.
Read Moreon 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:
Read Moreon 26 October 2012 | By Ryan Kasun
This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
Read Moreon 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...
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 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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