Regulatory Strategy for Medical Devices Essentials Training by Tonex
This course provides a practical overview of global regulatory frameworks for medical devices. It covers key compliance, approval, and post-market strategies. Participants learn how to navigate regulatory bodies such as FDA, EMA, and others. Emphasis is placed on risk classification, submissions, and labeling. A special focus is given to cybersecurity regulations impacting device safety and patient data protection. Strong regulatory strategy improves security posture and ensures compliance with medical device cybersecurity standards.
Audience:
- Regulatory affairs professionals
- Medical device developers
- Cybersecurity professionals
- Quality assurance teams
- Healthcare compliance officers
- Product managers in MedTech
Learning Objectives:
- Understand the medical device regulatory lifecycle
- Identify key global regulatory bodies and requirements
- Develop risk-based regulatory strategies
- Integrate cybersecurity into compliance planning
- Manage documentation for approval and post-market activities
Course Modules:
Module 1: Global Regulatory Frameworks
- Overview of medical device regulations
- Classification systems and device risk levels
- FDA and EU MDR regulatory pathways
- Regulatory bodies across key global markets
- Impact of regulations on product development
- Cybersecurity compliance across jurisdictions
Module 2: Regulatory Strategy Development
- Elements of an effective regulatory strategy
- Market access and entry planning
- Regulatory intelligence gathering
- Developing a regulatory roadmap
- Identifying critical compliance milestones
- Aligning cybersecurity strategy with compliance
Module 3: Risk Classification and Pathways
- Device classification criteria
- Premarket submission types (510(k), PMA, De Novo)
- Determining appropriate regulatory pathways
- Cyber risk as part of device classification
- Use of guidance documents for pathway selection
- Interpreting classification decisions
Module 4: Submission Preparation and Approvals
- Preparing regulatory submission documents
- Common pitfalls in regulatory submissions
- Technical documentation and clinical evidence
- Cybersecurity content in premarket submissions
- FDA eSTAR and EU MDR technical file
- Communication with regulatory authorities
Module 5: Post-Market Surveillance and Compliance
- Post-market surveillance planning
- Incident reporting and corrective actions
- Regulatory audits and inspections
- Cyber incident response in post-market phase
- Labeling and promotional material compliance
- Lifecycle regulatory updates
Module 6: Cybersecurity and Regulatory Integration
- Medical device cybersecurity frameworks
- FDA premarket guidance on cybersecurity
- EU MDR cybersecurity expectations
- Coordinated vulnerability disclosure policies
- Integration of threat modeling into submissions
- Harmonizing cybersecurity and regulatory documentation
Gain a competitive edge in the MedTech industry. Enroll now to master regulatory strategy and strengthen your cybersecurity compliance.