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.
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Suggested Topics
- A short history of the FDA and drug and device regulations
- The inspectional role of FDA and its device regulatory sanctions
- Quality System elements essential to the US FDA and international regulatory bodies
- Internal and contractor audits
- Device risk analysis
- SOPs: authoring, reviewing, approving, and training
- Good device documentation practices
- Production and process controls (including equipment controls, automated process controls, validation/qualification, acceptance criteria, and labeling, packaging, storage, and distribution)
- Management Quality Controls and responsibilities (including management commitment, authority, communication, and review)
- Design Quality Controls (QbD), including change control
- Production and Process Quality Controls
- Complaint handling, including Serious Adverse Events (SAEs)
- Medical device reporting to FDA
- Device failure investigations and establishing CAPA (Corrective and Preventive Action) initiatives