In response to krp67: Is there “generic form” that you proposed a suggestion that the regulating body for medical devices should be a global organization? Or is your suggestion that a company’s documentation should be formatted in such a way that it is compliant for all major regulating bodies throughout the world?

I do not think that a global regulating body for medical devices would be realistic for various political reasons, however I think that the second situation that I described could save a lot of time for a company when they try to enter new markets. However, sometimes a company does not have time to redesign their entire infrastructure. For example, I am currently working on a multiple phase project that is focused on updating documentation from a legacy product to ensure that it is compliant with today’s standards. Since the majority of the market for this product is located in Europe, the project plan’s first priority is to make sure that the product is compliant with all of the EU’s standards for medical devices. Once that is complete, we will be doing the same thing for the US market and the FDA. This means that a lot of the work that we already did will need to be transferred to different documentation. If we had standardized documentation that could work for both, then we would have been able to avoid doing the same thing twice. However in the interest of completing the project without any unnecessary delays, existing documentation forms were used.