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 follow all hockey writers in the next 24 hours or so, I find myself thinking about trades in medical devices.
[fa icon="clock-o"] 4/3/13 7:11 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] trade, MDD, Medical Devices, trade deadline, trade-off, nhl, iso 14971, risk management, 14971, FDA, business risk, cmdr
Read More »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 evidence of compliance.
[fa icon="clock-o"] 3/5/13 6:11 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] standards, european commission, IEEE, MDD, Medical Devices, BSI, medical device field, medical device manufacturer, country code, FDA, ASTM, RTCA
Read More »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!).
[fa icon="clock-o"] 2/8/13 8:47 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] QMS, MDD, EU, Canada, Medical Devices, FDA, health canada, 21 cfr 820, Preventive Action, iso 13485
Read More »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. After a little digging into the changes to EN ISO 14971 and EN ISO 13485, hopefully I can provide you with a little clarity.
[fa icon="clock-o"] 2/7/13 9:25 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] standards, MDD, iso 14971, medical device, Medical Device Directive, ISO, iso 13485
Read More »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.
[fa icon="clock-o"] 1/30/13 8:13 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] 13485, MDD, EU, Quality Management System, Quality System, Product Quality, FDA, medical device, 21 cfr 820, Joseph Juran, quality
Read More »Wrap-up of a few notable news stories from last week:
[fa icon="clock-o"] 1/21/13 7:57 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] listing, MDD, EU, Medical Devices, us, gmp, mdufa III, FDA, FDASIA, enforcement actions, registration
Read More »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.
[fa icon="clock-o"] 12/20/12 4:30 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] MDD, EU, FDA, health canada, medical device, cleveland
Read More »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.
[fa icon="clock-o"] 12/17/12 8:13 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] MDD, EU, label, Regulatory Affairs, RQS, labeling, ifu, FDA, health canada, medical device, user guide, instructions for use, manual
Read More »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.
[fa icon="clock-o"] 12/12/12 10:46 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] Biocompatibility, MDD, EU, Medical Devices, 10993-1, FDA, health canada, medical device, Medical Device Directive, 10993
Read More »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.
[fa icon="clock-o"] 12/11/12 4:09 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] MDD, EU, end user, FDA, health canada, medical device, customer
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