Medical Device Training
Medical devices range from simple products such as sutures to complex devices including surgical lasers and implantable devices such as pacemakers; and are regulated in the US by CDRH (Center for Devices and Radiological Health).
Medical device manufacturers must follow FDA regulations to ensure quality medical device production. Annual training is an FDA expectation whether your company is a virtual medical device organization or a CMO with hands-on manufacturing.
Sponsor companies are responsible for the safety and integrity of their product regardless of where that product is manufactured.
This program presents the essentials of the device GMPs / Quality System Regulations (QSR, 21 CFR 820), and is designed to promote employee compliance to FDA regulations.
This course can be customized to meet your company’s specific needs; including customization for various functional groups such as production, R&D, laboratory personnel, QA/QC, Senior and middle management, etc. You can select from our listed topics or if there are specific concerns at your organization, we can incorporate topics that are relevant to your team.
The training will include recent examples of FDA Warning Letters and 483s, as appropriate.