Gathering Clinical Evidence for Medical Devices

22, 23, 24 November 2022 | Hybrid | London

£795.00£1,895.00

Register for Module 1-Free (delivered online)

Gain a comprehensive understanding of the clinical data required for your device for CE marking under the MDR.

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Enrol before | 7 October to save 20% | 3 November to save 10%

Discount is applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,895 and live online is £1,595.

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.

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver both online and classroom training courses. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.

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.

 

We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.

Multiple Booking Options

 

  • 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)

What is Included in a Live Online Course?

 

  • Direct access to an expert trainer
  • 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

Key Learning Objectives

 

  • 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

Learn more about the course by toggling through the tabs below (trainer, venue, who should attend?)

Classroom Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. The final day may start and finish earlier to accommodate peoples travel arrangements.

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

28 September | 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.

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Day 1

22 November 2022

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

23 November 2022

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

24 November 2022

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.

Richard Young has over 30 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.

Gary M Creed has over 30 years’ experience in Healthcare and Clinical Diagnostics, Clinical Research Studies and Evaluations and the Medical Device Industry. He has worked as an Independent Subject Matter Expert, Clinical Presenter and Clinical Trials Specialist for multiple Medical Device and Diagnostic Companies and Disciplines and lectured and presented across the world. Gary has extensive experience in Regulatory Affairs, GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) and conducting Clinical Trials in a Healthcare setting in the UK and Internationally. Gary has held roles in healthcare as Laboratory Operations Manager and Head of Technical and Laboratory Services, Clinical Research Associate and Principal Investigator, Project Manager and Business Operations Management.

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.

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.

 

The course is held in the following venue:

Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ

 

Link to the Google Map

Learn more about the course by toggling through the tabs below (trainer, agenda,  who should attend?)

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

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.

 

Frequently asked questions (FAQs)

Could your team benefit from this course?

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.

*

• 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.