Build a solid foundation in medical device development by combining risk management, quality management, and software standards in one training.
This bundle includes:
Master Medical Device Compliance – All Essential Standards in One Bundle
Learn ISO 14971, ISO 13485, and IEC 62304 – and build a complete understanding of medical device development, risk management, and regulatory compliance
447,00€ 249,00€
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✔ 8+ hours of video training
✔ 200+ pages of training material
✔ 60 days access (Single license)
✔ Practical examples and real-world use cases
✔ Quizzes and structured learning path
What you'll learn
- Understand the full medical device development landscape
- Learn how risk management, quality, and software interact
- Apply ISO 14971, ISO 13485, and IEC 62304 together
- Build a compliant development process from end to end
- Prepare for audits and regulatory inspections
- Understand real-world implementation, not just theory
- Avoid common mistakes across multiple standards
What you will master in this bundle
ISO 14971 – Risk Management
- Hazard identification and risk analysis
- Risk evaluation and control
- Residual risk and benefit-risk analysis
ISO 13485 – Quality Management
- QMS structure and implementation
- Management responsibility and audits
- CAPA and continuous improvement
IEC 62304 – Software Lifecycle
- Software development processes
- Risk management for software
- Configuration and problem resolution
Course Preview: Get a Real Insight into the Training
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