Medical device regulators around the world often have to assess the cost of a new regulation. Typically there is a study to determine the financial effect on industry and the public. This information is often supplied to lawmakers in their respective countries before they pass new legislation. In contrast, and because they are voluntary and not legal requirements, technical standards created by ISO, IEC, and other standards development organizations are not screened or vetted with the same degree of accountability. This is partly why regulators insist that such privately created standards remain voluntary.

 …