Module #1 Introduction to Medical Device Regulations Overview of the importance of regulations and compliance in the medical device industry
Module #2 Global Regulatory Frameworks Comparison of regulatory frameworks in the US, EU, Canada, and other regions
Module #3 FDA Regulations for Medical Devices In-depth review of FDA regulations, including device classification, 510(k) clearance, and PMA approval
Module #4 EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) Understanding the EUs MDR and IVDR, including device classification, CE marking, and technical documentation
Module #5 Health Canada Regulations for Medical Devices Overview of Health Canadas regulatory requirements, including device licensing and compliance
Module #6 Risk Management and ISO 14971 Introduction to risk management principles and ISO 14971, including risk analysis and mitigation strategies
Module #7 Design Controls and Design Verification Best practices for design controls, including design inputs, design outputs, and design verification
Module #8 Manufacturing and Quality Control Overview of manufacturing regulations, including Good Manufacturing Practices (GMPs) and quality control procedures
Module #9 Labeling and Packaging Regulations Regulatory requirements for labeling and packaging, including UDI and CE marking
Module #10 Clinical Trials and Investigations Overview of clinical trial regulations, including IDE and CTA submissions
Module #11 Post-Market Surveillance and Vigilance Regulatory requirements for post-market surveillance, including adverse event reporting and recall procedures
Module #12 Compliance and Enforcement Overview of compliance and enforcement mechanisms, including inspections, audits, and warning letters
Module #13 Quality Management Systems (QMS) and ISO 13485 Introduction to QMS principles and ISO 13485, including quality policy, objectives, and processes
Module #14 Auditing and Inspection Preparation Best practices for preparing for audits and inspections, including auditor expectations and common findings
Module #15 Supply Chain and Vendor Management Regulatory requirements for supply chain management, including vendor selection and oversight
Module #16 Software and Cybersecurity Regulations Overview of software and cybersecurity regulations, including IEC 62304 and FDA guidelines
Module #17 Compliance for Combination Products Regulatory requirements for combination products, including drug-device and biologic-device combinations
Module #18 Regulatory Submissions and Filings Best practices for preparing and submitting regulatory filings, including 510(k), PMA, and CE marking technical files
Module #19 Regulatory Intelligence and Landscape Understanding the regulatory landscape, including emerging trends, guidance documents, and legislation
Module #20 Change Management and CAPA Best practices for change management and corrective action and preventive action (CAPA) procedures
Module #21 Training and Competency Regulatory requirements for training and competency, including employee training and certification
Module #22 Compliance for Start-Ups and Small Businesses Regulatory compliance strategies for start-ups and small businesses, including resource management and outsourcing
Module #23 Global Harmonization and Convergence Overview of global harmonization efforts, including ICH, IMDRF, and other initiatives
Module #24 Course Wrap-Up & Conclusion Planning next steps in Regulations and Compliance for Medical Devices career
