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Device Safety and Vigilance (English) Course & Certification
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Device Safety and Vigilance (English)
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About
Device Safety and Vigilance focuses on the monitoring, evaluation, and reporting of adverse events and product issues associated with medical devices throughout their lifecycle. It ensures that device-related risks are identified early and managed effectively to protect patient safety and maintain regulatory compliance.
This Device Safety and Vigilance (English) Course & Certification provides a comprehensive overview of global medical device vigilance systems, including adverse event reporting, regulatory requirements, complaint handling, and risk management. The course covers the history of device safety reporting, definitions and terminology, assessment of device-related incidents, global reporting frameworks (US, EU, Canada, Australia, Japan), complaint investigation processes, and trend analysis techniques. Upon completion, learners receive a certification demonstrating their understanding of international device safety and vigilance standards.
Who Should Enrol ?:
- Medical Device Vigilance and Safety Professionals
- Regulatory Affairs and Compliance Specialists
- Quality Assurance (QA) and Quality Control (QC) Personnel
- Clinical Affairs and Post-Market Surveillance Teams
- Medical Device Manufacturers and Suppliers
- Complaint Handling and CAPA Teams
- Biomedical Engineers and Device Risk Managers
- Pharmacovigilance and Drug Safety Professionals transitioning to device safety
- Life Science, Pharmacy, Engineering, and Medical Graduates
- Anyone involved in medical device safety, reporting, or compliance
What you will learn
Understand medical device safety, vigilance systems, and the history and importance of medical device reporting regulations.
Learn adverse event reporting terminology, device vigilance processes, causality assessment, and evaluation of medical device safety events.
Develop knowledge of global reporting requirements, including FDA, EU, Canadian, Australian, and Japanese medical device reporting regulations.
Gain understanding of customer complaint handling, trend analysis, risk management, device classification, and compliance practices for medical device safety monitoring.
Course Syllabus
- Learning Objectives for This Module
- History of Medical Device Reporting I
- History of Medical Device Reporting II
- History of Medical Device Reporting III
- History of Medical Device Reporting IV
- What Is Medical Device Reporting (MHRA Perspective)?
- Device Trials
- Pre-marketing ADEs
- Post-marketing ADEs
- FDA Requirement for MDRs
- Sources of MDRs I
- Sources of MDRs II
- Medical Device Report Types I
- Medical Device Report Types II
- Device Vigilance Definitions I
- Device Vigilance Definitions II
- MDR Reportable Events
- Acronyms Used for Device Safety
- The Device Vigilance Process
- Assessing Device Adverse Events
- Serious Adverse Events for Devices
- Examples of Life-Threatening Adverse Events I
- Examples of Life-Threatening Adverse Events II
- Intensity
- Serious vs. Severe
- Intensity and Seriousness – Question 1
- Intensity and Seriousness – Question 2
- Intensity and Seriousness – Question 3
- Intensity and Seriousness – Question 4
- Intensity and Seriousness – Answers I
- Intensity and Seriousness – Answers II
- Causality I
- Causality II – Difficulty in Establishing
- Causality III
- Causality IV – Classifications
- Causality V – Definitely Related
- Causality VI – Probably Related
- Causality VII – Possibly Related
- Causality VIII – Unlikely
- Lack of Efficacy
- Relationship Testing
- Unanticipated ADE
- Meaning of Anticipated
- Matrix of Global Safety Regulations
- US Postmarketing Requirements for Devices
- Requirements of FDA MDR Regulations
- Date of Awareness
- US Expedited Reporting I
- MDR Decision Tree
- US Reporting – Summary Matrix
- Malfunction Reporting
- US Reporting – Clinical Trials
- Alternative Summary Reporting
- European Expedited Reporting
- EU Criteria for Reporting
- Indirect Harm (EU Definition)
- European Reporting – Post-Marketing
- European Reporting – Clinical Trials
- New EU Regulations on Medical Devices
- Canadian Expedited Reporting
- Australian Expedited Reporting
- Japanese Expedited Reporting
- Customer Complaints
- Complaint Files – Procedure
- Customer Complaint, MDR, CAPA Flowchart
- Complaint Files – MDR I
- Complaint Files – MDR II
- MDR Reporting Requirement
- MDR 5-Day Report
- Non-MDR Complaints
- Trend Analysis
- Medical Device Safety and Risk Assessment
- US FDA National Medical Device Curriculum
- Risk Assessment – US
- Class of Device – US
- US Device Class I
- US Device Class II
- US Device Class III
- US Medical Devices Classification
- Class of Device (Ex-US)
- Risk Management
- Sample Trend Analysis I
- Sample Trend Analysis II – By Device Problem
- Sample Trend Analysis II – By Event Type
- Sample Trend Analysis II – By Remedial Action
- 📘 Bonus: Device Safety and Vigilance eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
Fully compliant
This course describes the compliance requirements for the reporting of adverse events relating to medical devices. Learners also receive 4 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
Reliable and trustworthy
This course was written by Steve Jolley, a recognised expert in International drug and device vigilance. You will stay up to date with any international legislative changes in device vigilance as our training courses are constantly monitored, reviewed and updated (last updated in May 2018). Steve Jolley is a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signaling.)
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