Regulations and Compliance for Medical Devices
( 24 Modules )

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

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Regulations and Compliance for Medical Devices ( 24 Modules )

Regulations and Compliance for Medical Devices
( 24 Modules )