Hybrid Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For classroom attendees, refreshments are served from 8:30 AM. For online attendees, you will receive joining instructions. 

24 & 25 November 2026

Register at the top of the page.

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

10 September 2026 | 1:00 PM (UK)

Delivered Online

Foundations of Clinical Evaluation

• Overview of clinical evaluation within MDR and global regulatory frameworks
• Key concepts: safety, performance, benefit–risk, and state of the art
• Understanding the role of clinical evaluation across the product lifecycle
• Short knowledge checks to reinforce core principles

Day 1

Clinical Evaluation Foundations and Strategy

• Understanding clinical evaluation in the regulatory framework versus real-world practice
  • Short quizzes to test understanding of key concepts and regulatory expectations
• Translating intended purpose into clinical evidence requirements
  • Review and critique of example intended purpose statements and clinical strategies
  • Case-based exercises to define clinical evidence requirements for different device types
• Defining and using state of the art (SOTA) to support clinical strategy and benefit-risk evaluation

Identifying and Generating Clinical Evidence

• Identifying appropriate types of clinical evidence (clinical investigations, literature, post-market data, non-clinical data)
• Practical approaches to literature searches and clinical data generation
• Matching clinical questions to the most appropriate types of evidence
• Understanding when and how equivalence can be used, and its limitations
  • Practical exercises on equivalence assessment using real-world style examples

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

Appraising Evidence and Demonstrating Sufficiency

• Appraising and “weighting” clinical evidence to support conclusions
• Determining when clinical evidence is sufficient — and what to do when it is not
  • Group exercises to assess benefit–risk in different clinical scenarios
• Managing clinical evidence gaps, including when clinical investigations may not be feasible
  • Scenario-based exercises exploring when clinical investigations are (and are not) required
  • Group discussions on sufficiency of evidence and how to address gaps

Advanced Scenarios and Lifecycle Evidence Planning

• Addressing special scenarios (e.g. unmet need, well-established technologies)
  • Discussion of challenging cases (e.g. limited data, novel devices, feasibility constraints)
• Linking clinical evaluation to post-market requirements and lifecycle evidence planning

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.

Amie Smirthwaite is a clinical and regulatory affairs expert with over 30 years’ postdoctoral experience in medical devices spanning new product development, quality and regulatory systems, and clinical evidence. She has been involved in the development of several MDCG and other clinical evaluation guidance documents and has served on numerous advisory board positions, including CORE-MD, HEU-EFS, and NORE, amongst others. She is a Board member and Chair of the Education Committee for ICEPS, the International Clinical Evidence Professionals Society, and serves as an independent expert for the EU MDCG Clinical Investigations and Evaluations working group. She is an active participant in ISO TC 194/WG4, home of ISO 14155 (clinical investigation) and ISO 18969 (clinical evaluation) and wrote the initial draft of ISO 18969.

She currently works as an independent consultant advising on clinical and regulatory affairs, but previously worked for BSI, where she was Global Head of Clinical Compliance. Amie was BSI’s first Head of Clinical Compliance, building their clinical compliance team and leading the development of their clinical evaluation processes. She also developed extensive training materials while at BSI, including clinical evaluation, technical documentation, risk management, ISO 13485, EU MDR, and biological evaluation. Amie is a Fellow of the Regulatory Affairs Professional Society.