medical devices Tag

Posted By: Stephanie Bouzounis, Senior Communications Specialist The deadline for the ISO 13485:2016 transition is fast approaching. In less than a year from now, changes will have to be made in order for companies to keep their certifications. Background The International Organization for Standardization (ISO) is a non-governmental entity...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The European Union (EU) published a new Medical Device Regulation in May 2017, giving manufacturers three years before full implementation in 2020. There are several changes in this new regulation. In a whitepaper by BSI titled, “Planning for implementation of the...

Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical device manufacturers have much to think about when it comes to registering a product internationally. Different regions and countries have different standards for registration. With the impending divorce of the U.K. from the European Union, there are even more...