Enrol before | 20 September to save 20% | 18 October to save 10%
Discount has been applied to the price above. VAT, if applicable, will be added.
Course Overview
The Medical Device Regulation (MDR) requires clinical evidence to demonstrate safety and clinical performance of a medical device. Clinical data obtained through clinical evaluations and investigations is required to CE mark a device. For most devices, clinical data must also be collected when the device is on the market to maintain patient safety. The regulations and guidance documents as well as applicable standards are detailed and require careful interpretation for different types of devices.
This interactive course focusses on all aspects of clinical evidence. You will examine the latest requirements and guidance available to ensure that you collect the right type of evidence and sufficient evidence for your medical device. You will learn about the clinical evaluation process, clinical investigations and post market clinical follow up studies and data collection. You will also cover specific clinical documents including the clinical investigation plan, clinical investigation report, clinical evaluation plan, clinical evaluation report, clinical development plan, summary of safety and clinical performance as well as post market clinical follow up plans.
Gain a complete understanding of the clinical data required throughout the lifecycle of your medical device
Examine the clinical requirements in the EU MDR and latest UK regulations for UKCA mark
Examine clinical evidence requirements for Class I, IIa and III to ensure compliance
Learn how to conduct a clinical evaluation including literature search and review
Examine the components of the Clinical Evaluation Report (CER) to ensure yours contains enough information for your device(s)
Learn to maintain the CER post market surveillance and discover how it links to your risk management plan
Understand the clinical investigation requirements and guidances so you know when an investigation is needed
Examine the increasing importance of post market clinical follow up studies (PMCF)
Understand when a PMCF is required and learn how to design a successful post market clinical programme
Multiple Booking Options
When selecting 1 or 2-days, we will contact you confirming the day(s) you will be attending
Whole course – All three topics (3-days)
Clinical Evaluations (Day 1)
Clinical Investigations (Day 2)
PMCF (Day 3)
Combination – (select 2 of the 3 days)
Register For Free Online Session
There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Interactive and engaging sessions with exercises and discussions
Bitesize learning
Access to the Educo Life Sciences Training Portal
Unlimited access to the recordings for 4 to 5 weeks after the last session
Reinforcement session delivered 4 to 5 week after the course (online) providing you with extra time with the trainer
A validated certificate of attendance available for you to download
What is a Hybrid Training Course?
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.
The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For online attendees, you will receive joining instructions.
Post Learning Implementation Plan (PLIP)
Pre-course
Access to the Educo Training Portal
Submit your needs analysis and objectives for training by completing a simple online form
Action Plan
At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Reinforcement Session
Delivered 3 to 4 weeks after the training
It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module 1
FREE to Attend | Live & Recorded
6 October 2023 | 1:00 PM (UK)
Delivered Online
Regulatory, guidance and standards for gathering medical device clinical evidence
How does the regulation apply to gathering of clinical evidence
What guidance and standard documents need to be followed when gathering clinical evidence
Clinical evidence for different device classes and the procedures relative to each.
What data, when, why, and how
Clinical definitions and terminology
Register For Module 1 | Free
There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Day 1
1 November 2023
Clinical Evaluation – Part 1
How to conduct a clinical evaluation
The Clinical Evaluation plan contents and structure
Conducting a literature search, the methodology
Literature search protocols
State of the Art literature review and analyses
Clinical Evaluation – Part 2
The Clinical Evaluation Report (CER)
Equivalence and similar
Benefit risk determination and meeting the general safety and performance requirements
Learn to strategically maintain a CER post market with new data
Practical guidance to incorporate post market surveillance with the CER
Examining how regularly the CER should be updated
Evaluating examples of what can trigger an update such as new claims or new clinical data
Examining how the clinical evaluation links to the risk management plan
Identify residual clinical risks and determine whether post-market clinical follow-up is required
Practical exercises, group work and case studies
Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.
Day 2
2 November 2023
Clinical Investigations – Part 1
Overview of the relevant Directives and Guidance
The requirement for clinical data for Class I, IIa and III
Identify when a clinical investigation/trial is required
Scientific opinion process and expert panels
Clinical strategy for your device
Clinical Investigations – Part 2
Compliance with ISO 14155
Development of a clinical investigation and essential documents including CIP, CRF, IB
Incorporating risk management in your clinical investigation
Optimising the study design
Practical guidance for obtaining approvals for conducting clinical investigations including research ethics committees and competent authority
Practical exercises, group work and case studies
Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.
Day 3
3 November 2023
Post market data collection – Part 1
Strategically implementing a post market clinical programme
Examining the current requirements for PMCF studies
Understanding the growing role of PMCF studies
Discussing examples when a PMCF study is required for new claims or a line extension
Practical guidance to strategically manage PMCF studies for existing products
Linking PMCF studies back to the clinical evaluation
Development of vigilance and corrective action plans
The post market clinical follow up plan
The post market clinical follow up report
Post market data collection – Part 2
Strategically implementing a post market surveillance system
The post market surveillance plan
The post market surveillance report
Vigilance and adverse event reporting during regulatory and post market studies
Discussing how the post market data relates to the clinical evaluation process
Other documents required for compliance
The periodic safety update report
The summary of safety and clinical performance
The clinical development plan
Ensuring your documents meet the regulatory requirements
Notified body review of documents
Resources available to keep up to date
Practical exercises, group work and case studies
Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.
Janette Benaddi is a business mentor, international speaker/trainer and expert consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Throughout her career Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. In addition, she set up a very successful medical device CRO company in the late nineties which she later successfully sold to another large multinational organization in 2013. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical investigations/evaluations for the medical device industry, she has also provided training to Notified bodies on medical device studies as well as other medical companies. She is highly regarded as a medical device trainer with an exceptional ability to share her vast knowledge and expertise in an engaging manner.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. She has also received an honorary doctorate in Health Sciences form York St John’s University. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.
This course is designed for medical device professionals who are responsible for obtaining clinical evidence. This includes professionals in clinical evaluations and investigations. It is also relevant for professionals who require an understanding of medical device clinical requirements.
These include:
Regulatory Affairs
Clinical Evaluation Professionals
Clinical Investigation Professionals
Medical Writers
Learn more about the course by toggling through the tabs below (trainer, venue, who should attend?)
Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.
Submit your needs analysis and objectives for training by completing a simple online form
Action Plan
At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Reinforcement Session
Delivered 3 to 4 weeks after the training
It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Introductory Module 1
FREE to Attend | Live & Recorded
60 mins
Regulatory, guidance and standards for gathering medical device clinical evidence
How does the regulation apply to gathering of clinical evidence
What guidance and standard documents need to be followed when gathering clinical evidence
Clinical evidence for different device classes and the procedures relative to each.
What data, when, why, and how
Clinical definitions and terminology
Module 2
150 mins
Clinical Evaluation – Part 1
How to conduct a clinical evaluation
The Clinical Evaluation plan contents and structure
Conducting a literature search, the methodology
Literature search protocols
State of the Art literature review and analyses
Module 3
150 mins
Clinical Evaluation – Part 2
The Clinical Evaluation Report (CER)
Equivalence and similar
Benefit risk determination and meeting the general safety and performance requirements
Learn to strategically maintain a CER post market with new data
Practical guidance to incorporate post market surveillance with the CER
Examining how regularly the CER should be updated
Evaluating examples of what can trigger an update such as new claims or new clinical data
Examining how the clinical evaluation links to the risk management plan
Identify residual clinical risks and determine whether post-market clinical follow-up is required
Module 4
150 mins
Clinical Investigations – Part 1
Overview of the relevant Directives and Guidance
The requirement for clinical data for Class I, IIa and III
Identify when a clinical investigation/trial is required
Scientific opinion process and expert panels
Clinical strategy for your device
Module 5
150 mins
Clinical Investigations – Part 2
Compliance with ISO 14155
Development of a clinical investigation and essential documents including CIP, CRF, IB
Incorporating risk management in your clinical investigation
Optimising the study design
Practical guidance for obtaining approvals for conducting clinical investigations including research ethics committees and competent authority
Module 6
150 mins
Post market data collection – Part 1
Strategically implementing a post market clinical programme
Examining the current requirements for PMCF studies
Understanding the growing role of PMCF studies
Discussing examples when a PMCF study is required for new claims or a line extension
Practical guidance to strategically manage PMCF studies for existing products
Linking PMCF studies back to the clinical evaluation
Development of vigilance and corrective action plans
The post market clinical follow up plan
The post market clinical follow up report
Module 7
150 mins
Post market data collection – Part 2
Strategically implementing a post market surveillance system
The post market surveillance plan
The post market surveillance report
Vigilance and adverse event reporting during regulatory and post market studies
Discussing how the post market data relates to the clinical evaluation process
Module 8
150 mins
Other documents required for compliance
The periodic safety update report
The summary of safety and clinical performance
The clinical development plan
Ensuring your documents meet the regulatory requirements
Notified body review of documents
Resources available to keep up to date
Janette Benaddi is a business mentor, international speaker/trainer and expert consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Throughout her career Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. In addition, she set up a very successful medical device CRO company in the late nineties which she later successfully sold to another large multinational organization in 2013. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical investigations/evaluations for the medical device industry, she has also provided training to Notified bodies on medical device studies as well as other medical companies. She is highly regarded as a medical device trainer with an exceptional ability to share her vast knowledge and expertise in an engaging manner.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. She has also received an honorary doctorate in Health Sciences form York St John’s University. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.
This course is designed for medical device professionals who are responsible for obtaining clinical evidence. This includes professionals in clinical evaluations and investigations. It is also relevant for professionals who require an understanding of medical device clinical requirements.
These include: Regulatory Affairs | Clinical Evaluation Professionals | Clinical Investigation Professionals | Medical Writers.
Free First Module and Pricing
Module 1 is free to attend and is delivered online and is recorded.
To enrol onto module 1, please submit your details in the form.
Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
There are price tiers for this course. The dates of these are at the located above the course overview.
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Or please summarise your objectives by following the link. Get in touch.
*
• When selecting 1 or 2-days, we will contact you confirming the day(s) you will be attending
• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• In the event we do not have enough people on one of the options we will contact you to discuss switching. If for example we ask you to switch from classroom (in-person) to live online, we will refund you the difference in price.
