on 23 March 2022 | By RQM+ Subject Matter Experts
Until recently, many IVD manufacturers were able to make changes to the design or intended use of their devices with minimal consequences under IVDD (98/79/EC). With the transition to IVDR and the date of application just around the corner, that time window is quickly closing....
Read Moreon 21 December 2021 | By RQM+ Subject Matter Experts
Under the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), every IVD must have a Performance Evaluation Report (PER). PERs consist of three pillars: scientific validity, analytical performance and clinical performance. Collating data to satisfactorily address...
Read Moreon 16 December 2021 | By RQM+ Subject Matter Experts
The next key regulatory milestone for manufacturers with products on the European market is the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). A critical stage of IVDR planning is for manufacturers to assess whether they have enough clinical and performance...
Read Moreon 5 April 2017 | By Stephen Biernacki
Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in...
Read Moreon 22 August 2013 | By Ryan Kasun
A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!
Read Moreon 5 April 2013 | By Ryan Kasun
I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.
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 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 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 3 October 2012 | By Ryan Kasun
After a recent statement by the EU health commissioner, it appears that FDASIA's influence may have gone abroad. As the medical device industry gears up and is adapting to the changes that FDASIA brings, it may also have to prepare itself for even more changes heading our way.
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