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....
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 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:
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