R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

EU MDR: Assessing the Impact and Next Steps [Webinar]

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 the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: May 23rd, where discuss MEDDEV 2.7.1 & CERs.

Mobile Medical Applications - Most Reliable Apps, Internationally?

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

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.

A QMS Outcast: Preventive Action

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 nightmare with future Broadway stars re-enacting a root cause analysis!).

Architect of Quality – Part 2: The Human Dimension

Welcome to the second installment in our blog series featuring Joseph Juran, “Architect of Quality.”1 Today, we’re going to take a deeper look at one of his major contributions – the addition of the “human dimension” to management theory.

Regulatory Intel - Jan. 21, 2013

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

Mistake, I Think Not!

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 been numerous failed redevelopment efforts, and as far as sports teams go; well, I have yet to see a championship winning team. Jokes aside, I don’t think anyone can argue that the Northeast Ohio region has evolved into a world class leader in medical treatment, education and innovation in the health care industry.

Labels impact the device

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.

Biocompatibility - Simple, Right?

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 intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.

In Your Face

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.

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