RQM+ Medical Device and In Vitro Diagnostic Blog

on 24 October 2017 | By Stephen Biernacki

ISO has published a companion handbook to ISO 13485:2016, Medical devices-Quality management systems - Requirements for regulatory purposes. From AAMI: It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. It offers...

on 12 February 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...

on 7 November 2016 | By Stephen Biernacki

“Procrastination is the bad habit of putting of until the day after tomorrow what should have been done the day before yesterday.” - Napolean Hill It's really never too early, especially when it comes to renewing the certifications you need to keep your product on the market. In...

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 7 July 2016 | By Stephen Biernacki

Missed our latest webinar on this year's ISO 13485 changes? Now you can download the slides and recording. R&Q's Director of Regulatory Affairs Nancy Morrison and Client Solutions Advisor Christine Santagate walked through 10 tips for adopting the latest changes. From conducting...

on 11 May 2016 | By Stephen Biernacki

The world's most well known standards for medical device quality management have been updated for the first time since 2003. Released in March by the International Organization for Standardization, ISO 13485 provides the universal requirements for manufacturers and service...

on 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.

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 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....