Medical Device Vigilance
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Device Safety and Vigilance
Adverse event reporting and risk assessment for medical devices in key markets worldwide
An introduction to the principles of adverse event reporting and risk assessment as applied to medical devices in the US, Europe, and other key international markets. The US has the most developed device vigilance processes but the course also summarizes the situation in Europe, Australia, Canada and Japan too. With coverage of risk assessment, AE report types, causality and event types, this course is designed to give a solid grounding in all key aspects of vigilance within this +$300 billion sector. Updated: May 2018.
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- Average study time:
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4 hrs
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- Personal development points (CPD):
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4 points
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- Price:
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£79.00
Course Details
The Device Safety and Vigilance course gives you a good understanding of the basic principles of vigilance and risk analysis – the course covers the history of device vigilance & safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management.
Keeping devices on the market without interruption becomes more essential with soaring development costs. Successful navigation of adverse event reporting, trend analysis and risk assessment are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on device vigilance and safety.
Benefits for you
- 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.)
Course Syllabus
1. Learning objectives |
2. Brief History of Device Safety & Vigilance |
3. Adverse Event Reporting Terms & Definitions |
| What is Medical Device Reporting (MHRA perspective)? |
| Clinical vs. post-market ADEs - Clinical |
| Clinical vs. post-market ADEs - Post-marketing |
| FDA Requirements for MDRs |
| Sources of MDRs |
| Medical Device Report Types |
| Device Vigilance Definitions |
| MDR Reportable Events |
| Acronyms Used for Device Safety |
4. Assessing Adverse Event Reports |
| The Device Vigilance Process |
| Assessing Device Adverse Events |
| Serious Adverse Event for Devices |
| Examples of Life Threatening Adverse Events |
| Intensity |
| Serious Vs. Severe |
| Causality |
| Causality - difficulty in establishing |
| Causality - classifications |
| Causality - definitely related |
| Causality - probably related |
| Causality - possibly related |
| Causality - unlikely to be related |
| Causality - relationship testing |
| Lack of Efficacy |
| Unanticipated ADEs |
| Anticipated & Unanticipated AEs |
5. Global Reporting Requirements |
| Matrix of Global Safety Regulations |
| US Postmarketing Requirements for Devices |
| Requirements of FDA MDR Regulations |
| Date of Awareness |
| US Expedited Reporting I |
| US Expedited Reporting II - MDR Decision Tree |
| US Expedited Reporting III - Summary matrix |
| US Expedited Reporting IV - Malfunction Reporting |
| US Expedited Reporting V - Clinical trials |
| US Expedited Reporting VI - Alternative Summary Reporting |
| European Expedited Reporting I |
| European Expedited Reporting II - EC Criteria for Reporting |
| European Expedited Reporting III - Indirect Harm |
| European Expedited Reporting IV - post-marketing |
| European Expedited Reporting V - Clinical Trials |
| Canadian Expedited Reporting |
| Australian Expedited Reporting |
| Japanese Expedited Reporting |
6. Complaints |
| Definition of complaints |
| Complaint Files – Procedure |
| Customer Complaint Flowchart - MDR, CAPA |
| Complaint Files - MDR |
| MDR I - Reporting Requirements |
| MDR II - 5-Day Report |
| Non-MDR Complaints |
7. Trend Analysis & Risk Management |
| Trend Analysis |
| Device Safety & Risk Assessment |
| US FDA National Medical Device Curriculum |
| Risk Assessment |
| Class of Device - US |
| Device Class I |
| Device Class II |
| Device Class III |
| Class of Device - Non-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 |