Basic courses (Level 300) are somewhat technical and intended for medical device developers and people who plan to engage in medical development soon.
Total duration: 204 minutes.
Product Design
The 5 Product Design videos below provide a practical overview of the Design Controls process. Design Controls Subject Matter Experts and Process Owners should also read FDA 21CFR820 subpart C, Design Controls.
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Operations
The 5 Operations videos below provide a practical overview of each Operations process. Operations Subject Matter Experts and Process Owners should also read FDA 21CFR820, Quality System Regulation.
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Risk Management
The 8 Risk Management videos below provide a practical overview of the Health Risk Management process. The videos advocate a Risk Management process that is compliant with ISO 14971:2019 but also includes best practice recommendations that are not explicitly required by the standard. Risk Management Subject Matter Experts and Process Owners should thoroughly read ISO 14971:2019 to fully understand all of the Risk Management options and trade-offs available to medical device manufacturers.
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Note: Key terms mentioned in the videos above are defined in the Glossary which includes references.