Medical Device Approval Primer | CPE

- Level: Intermediate
- CPE: 1.50 Credits
- Time: 57 Munites
Navigate the complex world of medical device approvals by mastering FDA and EMA pathways, device classifications, and global quality standards like QSR, GLP, and GCP. Medical Device Approval Primer equips you to assess risk, choose the right regulatory strategy, and ensure patient safety.
- Understand the regulatory approval pathways medical devices must navigate to reach the market
- Discover key FDA submission types and their impact on development timelines and costs
- Learn how clinical evaluation, risk management, and post-market surveillance shape device approval and long-term success
- Best Value: Unlimited Learning
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- Up to 12-month unlimited access
- Content designed for all skill levels: Beginner to Advanced
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Get full access to this course with a one time purchase.
- 1-month access to all course material
- CPE credits included
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- Self-paced and on-demand
- Ideal for focused, one-off learning
- Overview
- Agenda
- Features
- Justify This Training
- FAQ
Watch Trailer
Agenda
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Medical Device Overview
Introduces regulatory considerations and approval pathways based on a medical device’s risk classification.
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Medical Device Regulation
Details key compliance regulations, including the Code of Federal Regulations, GLP, GCP, and cGMP, risk management planning, and global regulatory oversight.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
FAQ
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