FDA finalizes streamlined bundled, quarterly MDR reporting system


FDA 3D printingThe FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting.

The program was created in part through public comments received by the FDA and is intended to allow manufacturers to report “certain device malfunctions in summary form on a quarterly basis” instead of an an individual basis for certain devices.

Read the whole story on our sister site, MassDevice.com

Inside Hologic's evolving definition of women's healthcare

textadimage Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.

At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!


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