The medical device industry is undergoing a period of immense change. In 2016, there has been a new version of the ISO standard for the medical device industry, ISO 13485, as well as two new Regulations, for medical devices (including active implantable medical devices) and for in-vitro diagnostic devices. The changes require thorough understanding of the new requirements, and robust, efficient plans to ensure that all new requirements are met within the relevant transition periods.

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[ISO 13485]

Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell)