About This Learning Path
Master medical device regulations and quality management with our comprehensive Medical Device Quality Management certification. Covering US FDA and EU MDR requirements, ISO 13485:2016 QMS, and ISO 14971:2019 risk management, this certification ensures compliance from development to market. Learn essential concepts, regulatory definitions, risk assessment techniques like FMEA and FTA, and post-market obligations for a robust and compliant medical device management system.
Certification Syllabus:
Course 1: The Fundamentals of Medical Devices
Explore a high-level overview of some general medical device concepts and medical device classification information.
Course 2: US FDA - Medical Device Regulations
Explore the fundamentals of US FDA medical device regulations.
Course 3: EU MDR - Medical Device Regulation
Explore the fundamentals of EU MDR - Medical Device Regulation
Course 4: Product Life Cycle of Medical Devices
This course introduces the product life cycle of medical devices from product development to production, market introduction, and post-market follow-up.
Course 5: The Fundamentals of Medical Device QMS
Explore the key principles of international standards for medical device Quality Management Systems (QMS) under ISO 13485:2016.
Course 6: Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
Explore key requirements of medical device QMS ISO 13485:2016 (Clauses 0-4)
Course 7: Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
Explore key requirements of medical device QMS ISO 13485:2016 (Clauses 5 to 6)
Course 8: Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
Explore key requirements of medical device QMS ISO 13485:2016 (Clauses 7 to 8)
Course 9: An Introduction to Medical Device Risk Management: ISO 14971: 2019
This course covers the key concepts and regulations for medical device risk management.
Course 10: Risk Management Process for Medical Devices: ISO 14971: 2019
Master the ISO 14971 risk management process for medical devices, including SaMD and in vitro diagnostics.
Course 11: Risk Management for Medical devices with FMEA: ISO 14971: 2019
Find out how to manage risk for medical devices using the Failure Modes and Effects Analysis (FMEA) methodology.
Course 12: Managing Risk for Medical Devices with FTA: ISO 14971: 2019
Explore how to manage risk for medical devices using the Fault Tree Analysis (FTA) methodology.
Additional Information:
Who Should Attend: This certification is recommended for anyone interested in understanding the medical device industry. It is suitable for professionals involved in development, manufacturing, quality assurance, compliance, risk management, regulatory, marketing, and post-market obligations.
Certification Duration: Approximately 6 hours
Skill Level: Intermediate
Final Assessment: Yes (11 quizzes)
Certification Associated: Yes
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About This Learning Path
Master medical device regulations and quality management with our comprehensive Medical Device Quality Management certification. Covering US FDA and EU MDR requirements, ISO 13485:2016 QMS, and ISO 14971:2019 risk management, this certification ensures compliance from development to market. Learn essential concepts, regulatory definitions, risk assessment techniques like FMEA and FTA, and post-market obligations for a robust and compliant medical device management system.
Certification Syllabus:
Course 1: The Fundamentals of Medical Devices
Explore a high-level overview of some general medical device concepts and medical device classification information.
Course 2: US FDA - Medical Device Regulations
Explore the fundamentals of US FDA medical device regulations.
Course 3: EU MDR - Medical Device Regulation
Explore the fundamentals of EU MDR - Medical Device Regulation
Course 4: Product Life Cycle of Medical Devices
This course introduces the product life cycle of medical devices from product development to production, market introduction, and post-market follow-up.
Course 5: The Fundamentals of Medical Device QMS
Explore the key principles of international standards for medical device Quality Management Systems (QMS) under ISO 13485:2016.
Course 6: Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
Explore key requirements of medical device QMS ISO 13485:2016 (Clauses 0-4)
Course 7: Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
Explore key requirements of medical device QMS ISO 13485:2016 (Clauses 5 to 6)
Course 8: Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
Explore key requirements of medical device QMS ISO 13485:2016 (Clauses 7 to 8)
Course 9: An Introduction to Medical Device Risk Management: ISO 14971: 2019
This course covers the key concepts and regulations for medical device risk management.
Course 10: Risk Management Process for Medical Devices: ISO 14971: 2019
Master the ISO 14971 risk management process for medical devices, including SaMD and in vitro diagnostics.
Course 11: Risk Management for Medical devices with FMEA: ISO 14971: 2019
Find out how to manage risk for medical devices using the Failure Modes and Effects Analysis (FMEA) methodology.
Course 12: Managing Risk for Medical Devices with FTA: ISO 14971: 2019
Explore how to manage risk for medical devices using the Fault Tree Analysis (FTA) methodology.
Additional Information:
Who Should Attend: This certification is recommended for anyone interested in understanding the medical device industry. It is suitable for professionals involved in development, manufacturing, quality assurance, compliance, risk management, regulatory, marketing, and post-market obligations.
Certification Duration: Approximately 6 hours
Skill Level: Intermediate
Final Assessment: Yes (11 quizzes)
Certification Associated: Yes
