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. 

26 November 2026

Register at the top of the page.

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

Foundations of Clinical Evidence Generation

• The role of evidence generation within clinical evaluation
• Moving from clinical questions to an evidence generation strategy
• Overview of key evidence generation approaches:
  • Prospective clinical studies
  • Retrospective studies
  • Usability / human factors studies
  • Surveys and user feedback
  • Other sources of real-world data
• Comparison exercises exploring strengths and weaknesses of key approaches (including usability and surveys)

Selecting the Right Evidence Strategy

• Selecting appropriate approaches based on device, claims, and clinical evaluation conclusions
• Strengths and limitations of different evidence generation methods
• When clinical investigations are required — and when alternatives may be appropriate
• Group discussions on when clinical investigations are required versus avoidable
• Scenario-based exercises designing a simple pre-market evidence plan

Pre-Market vs Post-Market Evidence Planning

• Pre-market versus post-market evidence generation strategies
• PMCF as part of a lifecycle approach
• When reliance on literature, PMS, and lower-intensity methods may be justified
• Workshop to outline a proportionate PMCF / post-market evidence approach

Reviewing, Stress-Testing and Optimising Evidence Plans

• Identifying gaps, risks, and over/under-design in evidence strategies
• Aligning evidence generation with regulatory expectations and practical constraints
• Ensuring strategies are proportionate, defensible, and efficient
• Review of example strategies — identifying gaps, risks, and over/under-design 

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.