Sale

Gathering Clinical Evidence for Medical Devices

15 February 2022 | 2 Week Live Online Course

£480.00£1,120.00

Register for Module 1 | Free

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

Clear

Enrol before | 19 January to save 20% | 11 February to save 10%

*(discount is applied to price above)*

 

 

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.

 

Multiple Booking Options
  • Whole course – All three topics and PLIP (8 modules)
  • Clinical Evaluations – Modules 1, 2, 3 & 8
  • Clinical Investigations – Modules 1, 4, 5 & 8
  • PMCF – Modules 1, 6, 7 & 8
  • Combination – Combine two from Evaluations, Investigations or PMCF (6 modules)

 

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 live online training.

 

 

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 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file

Learn more about how we deliver live online training

 

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
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

31 January | 60 mins | 12 pm UK  

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

 

Leave this field blank
Module 2

15 February | 150 mins | 9.30 am UK

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

15 February | 150 mins | 1.30 pm UK

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

17 February | 150 mins | 9.30 am UK

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

17 February | 150 mins | 1.30 pm UK

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

22 February | 150 mins | 9.30 am UK

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

22 February | 150 mins |1.30 pm UK

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

24 February | 150 mins | 1.30 pm UK

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 for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • There are two price tiers for this course:
    • Super Early Bird Discount – Enrol approximately 3 to 5 weeks before the course starts.
    • Early Bird Discount – Enrol 7 to 10 days before the course starts.
    • The early bird dates for this course are at the top of the page, above 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 completing the form below.

Leave this field blank
  • Choose
  • Pharmaceuticals
  • Biotechnology
  • Cell and Gene Therapies
  • Medical Devices
  • Pharma/Biotech Regulatory Affairs
  • Choose
  • I am interested in a course
  • I am looking to train a group/team of people
  • General enquiry
  • I would like to subscribe to your mail list
  • Other

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.