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  • Chris Vasquez replied to the topic PM Internationally in the forum Project Management Process and Medical Device Development 8 years, 1 month ago

    I agree with the comments above, I believe that the biggest difference would be dealing with the diverse regulations. From my previous experience within a cosmetic standpoint, I was working on a reform on an overseas product, both the overseas product and the American product had the same ingredients, but the big difference is that the European body utilized a stearyl alcohol that was completely different from the Stearyl alchohol we used in our regular line, the main reason was because the one we used in our American line products was not approved by the European body. I was making a batch of hand cream and I accidently picked the European designated stearyl alchohol, so stearl alcohol for those who don’t know is an emulsifier that keeps creams and lotions stable. Well the European approved stearyl alcohol, did exactly the opposite of what it was intended to do, and this raw material needs another ingredient to become active. So in conclusion, the biggest challenge about going international with project management, is the ability to distinguish what is acceptable between different countries with regards to materials and standards, as well is communication and documentation.