Regulatory & Technical Training
Strategic, Practical Training for Complex Medical Device Development
CardioMed partners with sponsors to build internal expertise across regulatory, clinical, and engineering teams. Our training programs are designed to align cross-functional groups with FDA expectations and support efficient development of Class II and Class III devices.
Comprehensive Training
Across the Device Lifecycle
- FDA history and the Food, Drug, and Cosmetic Act
- FDA laws, regulations, and enforcement
- FDA organization and structure, including CDRH
- CDRH goals, initiatives, and review programs
- Medical device requirements across the product lifecycle
- 510(k), De Novo, and PMA pathways
- IDE requirements and clinical study considerations
- Medical device labeling requirements
- FDA guidance documents: interpretation and application
- Bench testing strategies and applicable standards (ISO, ASTM)
- Design verification and validation approaches
- Worst-case and risk-based testing methodologies
- ISO 10993 strategy and endpoint selection
- Material characterization and extractables/leachables
- Toxicological risk assessment
- Animal study design and model selection
- GLP considerations and study endpoints
- Translation of preclinical data to clinical performance
- Software verification and validation
- Cybersecurity and risk management
- AI/ML considerations and FDA expectations
Trusted Networks
Partners Supporting Training & Development
CardioMed maintains a network of trusted partners including CROs and specialized laboratories, supporting preclinical testing, clinical execution, and data analysis. We connect clients with high-quality providers tailored to their specific development and training needs, ensuring your team has access to the right resources at the right time.
The CardioMed Difference
Deep FDA experience and regulatory alignment ensuring training content reflects current and practical FDA expectations.
Strong expertise in preclinical testing and engineering evaluation delivered in a practical, applicable training format.
Senior-led, hands-on training approach with real-world experience — not theoretical lectures — giving your team actionable knowledge.
Integrated regulatory, clinical, and technical perspective throughout every training module for cross-functional team alignment.
Strengthen Your Team's
Regulatory Capabilities
Partner with CardioMed to build internal expertise with practical, FDA-aligned training programs tailored to your team.
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