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Mastering Clinical Evaluations for Medical Devices

26 April 2023 | Short Online Course

£396.00

Learn best practice for researching and writing clinical evaluations for your devices.

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Course Overview

 

The Medical Device Regulation (MDR) has put a great emphasis on clinical data to maximise safety of medical devices. Some of biggest changes in the MDR impact clinical evaluations and include, GSPRs that are more extensive, more detailed evidence to demonstrate equivalence, required through the device lifecycle and a new risk classification system. As a result, the clinical evaluation report (CER) is more detailed and complex.

 

This interactive course focusses on all aspects of clinical evaluations from the latest definitions and guidelines to conducting a literature research. Crucially, you will examine the writing of CERs, and how best to structure them according to your device. Finally, you will examine how to manage the CER throughout the lifecycle of your device from product inception all the way through to PMCF. Once completed you will be confident when writing CERs back in the workplace.

Key Learning Objectives

 

  • Review the latest guidances and how it is applied to the gathering of clinical evidence throughout the lifecycle of your 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
What is Included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session
Download the Agenda

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Course Information

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1

26 April 2023 | 180 mins | 9:30 AM 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

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

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.

Session 2

26 April 2023 | 180 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

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.

This course is designed for medical device professionals who are responsible for or contribute to the clinical evaluation of devices.

 

These include:

  • Regulatory Affairs
  • Clinical Evaluation Professionals
  • Clinical Investigation Professionals
  • Medical Writers
  • Consultants
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.

*

• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training