About the Course
⚠️ REGULATORY UPDATE NOTICE
Important: this course was developed under the previous Quality System Regulation (QSR). As of February 2, 2026, the FDA's amended Quality Management System Regulation (QMSR) is now in effect under 21 CFR Part 820.
What changed: the QMSR incorporates ISO 13485:2016 by reference and includes additional FDA-specific requirements.
What this means for you right now: while the core quality management principles in this course remain valid, specific regulatory references, terminology, and certain requirements may differ under the QMSR (more details coming soon).
Action required: always verify current regulatory requirements at www.fda.gov before implementation in your organization.
Please note: this course is scheduled for update to align with QMSR requirements in the near future. Additional information will be provided soon.
Introduction to this course:
This course guides you through the entire regulatory compliance journey for medical devices, from development to market access, encompassing FDA approval, EU MDR compliance, quality management systems (QMS), risk management, and post-market obligations.
Who should attend:
This course is designed for professionals involved in the EU medical device industry, particularly those in the development, and marketing of medical devices. The course is also suitable for anyone interested in understanding the medical device industry.
Learning Outcomes:
By the end of this lesson, you will be able to:
Recall key regulatory requirements for medical device development.
Interpret the phases of FDA approval and EU MDR compliance.
What will I gain:
Participants will gain a thorough understanding of global regulatory frameworks and practical skills in navigating medical device compliance, enhancing market readiness.
Prerequisites:
Participants should have a basic understanding of quality management systems and familiarity with medical device terminology and regulatory concepts.
Additional information:
Course duration: 00:25:03
Course code/version (effective date): L-147/v1.0 (25/09/2023)
Course Categories
-
Product life cycle of medical devices
- Lesson 1: Product Life Cycle: Regulatory fundamentals of medical devices in the US (Part 1)
- Lesson 2: Product Life Cycle: Regulatory fundamentals of medical devices in the US (Part 2)
- Lesson 3: Product Life Cycle: Regulatory fundamentals of medical devices in the US (Part 3)
- Course Study Guide
-
Additional resources
- Course Notes
- Mind map: Risk Management for Medical Devices
- Reading: A Guide to Bringing a Medical Device to Market
- Reading: The 5 Medical Device Development Phases
- Masterclass - Clinical Evaluation and Investigations with Medical Devices
-
Survey
- Course survey
About the Course
⚠️ REGULATORY UPDATE NOTICE
Important: this course was developed under the previous Quality System Regulation (QSR). As of February 2, 2026, the FDA's amended Quality Management System Regulation (QMSR) is now in effect under 21 CFR Part 820.
What changed: the QMSR incorporates ISO 13485:2016 by reference and includes additional FDA-specific requirements.
What this means for you right now: while the core quality management principles in this course remain valid, specific regulatory references, terminology, and certain requirements may differ under the QMSR (more details coming soon).
Action required: always verify current regulatory requirements at www.fda.gov before implementation in your organization.
Please note: this course is scheduled for update to align with QMSR requirements in the near future. Additional information will be provided soon.
Introduction to this course:
This course guides you through the entire regulatory compliance journey for medical devices, from development to market access, encompassing FDA approval, EU MDR compliance, quality management systems (QMS), risk management, and post-market obligations.
Who should attend:
This course is designed for professionals involved in the EU medical device industry, particularly those in the development, and marketing of medical devices. The course is also suitable for anyone interested in understanding the medical device industry.
Learning Outcomes:
By the end of this lesson, you will be able to:
Recall key regulatory requirements for medical device development.
Interpret the phases of FDA approval and EU MDR compliance.
What will I gain:
Participants will gain a thorough understanding of global regulatory frameworks and practical skills in navigating medical device compliance, enhancing market readiness.
Prerequisites:
Participants should have a basic understanding of quality management systems and familiarity with medical device terminology and regulatory concepts.
Additional information:
Course duration: 00:25:03
Course code/version (effective date): L-147/v1.0 (25/09/2023)
-
Product life cycle of medical devices
- Lesson 1: Product Life Cycle: Regulatory fundamentals of medical devices in the US (Part 1)
- Lesson 2: Product Life Cycle: Regulatory fundamentals of medical devices in the US (Part 2)
- Lesson 3: Product Life Cycle: Regulatory fundamentals of medical devices in the US (Part 3)
- Course Study Guide
-
Additional resources
- Course Notes
- Mind map: Risk Management for Medical Devices
- Reading: A Guide to Bringing a Medical Device to Market
- Reading: The 5 Medical Device Development Phases
- Masterclass - Clinical Evaluation and Investigations with Medical Devices
-
Survey
- Course survey