A Bit about CrossWind

The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. Speaking as the Quality Systems Director of CrossWind Machining (component manufacturer for the medical device industry) and just completing our ISO 13485:2016 Certification, the new 2016 revision (from 2003) is all about mitigating risk from every aspect of the medical device manufacturing process . And with ISO 13485:2003 no longer being valid after 2019, suppliers are having to decide how much time & money they are willing to put into separating themselves. What the new Standard Says About Risk One particularly   notable change with ISO 13485:2016   is the addition of more explicit risk management requirements. Companies will be required to consider the risk associated with a device from conception through its use. Device make...

For a lot of people, going to a four-year college seems like an automatic choice when they graduate from high school. The reason is obvious – higher income. According to the  National Center for Educational Statistics , a bachelor’s degree accounted for an average of $16,900 in additional income per year compared to a high school diploma ($30,000 versus $46,900). Over a 30-year career in the workforce, that’s more than a $500,000 difference in earnings. These numbers may not paint the whole picture, however. Due to the increasingly high costs associated with a college education, as well as other drawbacks, more and more people have been considering trade school as an education alternative.   Skilled labor is needs just as much as an educated work force! Trade School vs. College: Drawbacks to College Education Length: Four (or More) Years vs. Two Years For starters, a bachelor’s degree typically takes four years of study, which means that people who enter the wor...