Understanding the EU MDR
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1. Introduction
Introduction to the MDR
Supporting Information - Understanding the EU MDR
Structure of the MDR
MDR requirements
What is a medical device
2. Understanding requirements
Classifying medical devices
Making devices available on the market
General Safety and Performance Requirements (GSPRs)
3. QMS, PMS & Risk Management
Quality Management Systems & Post-Market Surveillance
Basic principles of Risk Management
Benefits of Risk Management
4. Clinical Evaluation
Clinical Evaluation & CERs
Basic principles of planning a CER
5 common pitfalls for a CER
Our Clinical Evaluation services
5. Gap Analysis & Document Management
Gap Analysis Tool
Document Management
Importance of Document Management
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Course
Understanding the EU MDR
Understanding the EU MDR
Understanding the EU MDR
Buy now
Learn more
1. Introduction
Introduction to the MDR
Supporting Information - Understanding the EU MDR
Structure of the MDR
MDR requirements
What is a medical device
2. Understanding requirements
Classifying medical devices
Making devices available on the market
General Safety and Performance Requirements (GSPRs)
3. QMS, PMS & Risk Management
Quality Management Systems & Post-Market Surveillance
Basic principles of Risk Management
Benefits of Risk Management
4. Clinical Evaluation
Clinical Evaluation & CERs
Basic principles of planning a CER
5 common pitfalls for a CER
Our Clinical Evaluation services
5. Gap Analysis & Document Management
Gap Analysis Tool
Document Management
Importance of Document Management
Learn more
Buy now
Gain clarity & context on overall EU MDR requirements for your entire medical device regulatory strategy.
1. Introduction
5 Lessons
Introduction to the MDR
Supporting Information - Understanding the EU MDR
Structure of the MDR
MDR requirements
What is a medical device
2. Understanding requirements
3 Lessons
Classifying medical devices
Making devices available on the market
General Safety and Performance Requirements (GSPRs)
3. QMS, PMS & Risk Management
3 Lessons
Quality Management Systems & Post-Market Surveillance
Basic principles of Risk Management
Benefits of Risk Management
4. Clinical Evaluation
4 Lessons
Clinical Evaluation & CERs
Basic principles of planning a CER
5 common pitfalls for a CER
Our Clinical Evaluation services
5. Gap Analysis & Document Management
3 Lessons
Gap Analysis Tool
Document Management
Importance of Document Management