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Certification
Medical Device Quality Management
Medical Device Quality Management

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

Start Path
Pre Certification Assessment: Medical Device Quality Management
Pre Certification Assessment: Medical Device Quality Management
An introduction to medical device risk management: ISO 14971:2019
An introduction to medical device risk management: ISO 14971:2019
The fundamentals of medical devices
The fundamentals of medical devices
US FDA - Medical Device Regulations
US FDA - Medical Device Regulations
EU MDR - Medical Device Regulation
EU MDR - Medical Device Regulation
Product life cycle of medical devices
Product life cycle of medical devices
The fundamentals of medical device QMS
The fundamentals of medical device QMS
Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
Risk management process for medical devices: ISO 14971:2019
Risk management process for medical devices: ISO 14971:2019
Risk management for medical devices with FMEA: ISO 14971:2019
Risk management for medical devices with FMEA: ISO 14971:2019
Managing risk for medical devices with FTA: ISO 14971:2019
Managing risk for medical devices with FTA: ISO 14971:2019
Final Certification Assessment: Medical Device Quality Management
Final Certification Assessment: Medical Device Quality Management

Scilife Academy Certificate

Certification
Medical Device Quality Management
Medical Device Quality Management
Start Path

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

Pre Certification Assessment: Medical Device Quality Management
Pre Certification Assessment: Medical Device Quality Management
An introduction to medical device risk management: ISO 14971:2019
An introduction to medical device risk management: ISO 14971:2019
The fundamentals of medical devices
The fundamentals of medical devices
US FDA - Medical Device Regulations
US FDA - Medical Device Regulations
EU MDR - Medical Device Regulation
EU MDR - Medical Device Regulation
Product life cycle of medical devices
Product life cycle of medical devices
The fundamentals of medical device QMS
The fundamentals of medical device QMS
Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4
Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6
Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
Risk management process for medical devices: ISO 14971:2019
Risk management process for medical devices: ISO 14971:2019
Risk management for medical devices with FMEA: ISO 14971:2019
Risk management for medical devices with FMEA: ISO 14971:2019
Managing risk for medical devices with FTA: ISO 14971:2019
Managing risk for medical devices with FTA: ISO 14971:2019
Final Certification Assessment: Medical Device Quality Management
Final Certification Assessment: Medical Device Quality Management

Scilife Academy Certificate

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