By David DelCollo, Attorney It has been 13 years since the last set of requirements and guidelines was released, but this year, the ISO will be launching ISO 13485:2016. This new release will have a substantial impact on the design, development, production, installation, and delivery of medical devices and related services,-but what exactly will the introduction of these new regulations mean to your organization? The primary requirements and guidelines for medical device designers and manufacturers are established by the International Organization for Standardization (ISO), which is an independent, non-governmental international organization with a membership of 162 national standard bodies, including North America and Europe. The main objective of the ISO, as...

By David DelCollo, Attorney Before Your Fear of Donald Trump Drives You to Pack Your Bags and Depart for Lands Unknown, You May Want to Take a Brief Look at the Lives of Some of Our Past Presidents. The political landscape these days appears to be more like a reality show starring Donald Trump than a presidential election. And while some people are absolutely convinced that Donald Trump as president would be the end of the civilized world as we know it, I beg to differ. First and foremost, let me say that I am in no way endorsing Donald Trump or any other presidential candidate for that matter. Rather, I believe that while Donald Trump may have his flaws and failings, he certainly would not be the first to break the mold of our “ideal” American President. Leading...