The Center for Devices and Radiological Health has posted new online learning tools for devicemakers on postmarket activities, importing medical devices into the United States, and the 510(k) third-party review program.
The interactive lessons include videos, audio recordings and slide presentations so users can select the format that suits them and work through the information at their own pace.
A module on postmarket activities includes an overview of the quality system, exporting devices to the U.S., device recalls, inspections and global harmonization activities. A separate module on production and process controls explains how devicemakers can ensure that their products meet specifications. A third module on the 510(k) third-party review program includes a guide for third-party reviewers.
Access the training modules here: bit.ly/2T2oQ3T.