RQM+ Medical Device and In Vitro Diagnostic Blog

on 29 May 2024 | By Scott Edwards, Managing Director, RQM+

Most of us are familiar with the fast-paced world of MedTech and the mounting pressures to maintain product quality, safety, and compliance companies face. With the FDA increasing the number of Class I recalls and the EU MDR/IVDR placing greater responsibilities on the Person...

on 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...

on 28 April 2016 | By Stephen Biernacki

If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop at BIOMEDevice in April, here's a second chance. A similar presentation and discussion will be offered in conjunction with MassMEDIC on Wednesday, May 18th at 11:30am EST. All the details - including...

on 15 April 2016 | By Stephen Biernacki

Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA compliance problems during R&Q's afternoon workshop at BIOMEDevice earlier this week? If so, we have news especially for you: he will be presenting on a similar topic via a webinar on Monday, May 9th...

on 13 April 2016 | By Stephen Biernacki

There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer: R&Q's Jake O'Donnell. This is your free, ultimate...

on 8 March 2016 | By Stephen Biernacki

Those in the northeast, get ready! Not only will R&Q be exhibiting at this year's BIOMEDevice show (booth 640) and sponsoring MassMEDIC's Annual Conference, but we'll be presenting an afternoon training workshop (three separate sessions) free to attendees of the BIOMEDevice show...

on 23 May 2013 | By Ryan Kasun

Why is it that Internal Audits are forgotten, or even worse feared? Why is it so many organizations of today place so much focus on the creation of Quality Procedures, Work Instructions, Forms, etc. but do not place the same focus on conducting internal audits of the quality...

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 4 February 2013 | By Ryan Kasun

'Tis the season for auditing. The beginning of this year, just like years in the past, seems to have brought the New Year's Resolution that audits will be scheduled and conducted to correct the sins of the previous year and take a fresh look at the upcoming year. To this point...

on 23 October 2012 | By Ryan Kasun

With recent clients I have been dealing more and more with new standards coming out or revisions being made to standards. This has got me thinking a lot about how to keep up with current standards. What is the best way of being notified of new releases of standards as well as...