Purpose & Learning Outcomes

Generating robust clinical evidence is no longer just a regulatory requirement—it's a strategic advantage. Whether seeking market access in Europe or expanding globally, manufacturers must demonstrate the safety, clinical performance, and clinical benefits of their medical devices with confidence.

This comprehensive two-day course explores the complete clinical evidence journey, from early product development through post-market surveillance. Participants will gain practical insights into the recently published ISO 18969*, which defines the clinical evaluation process, and understand how it interrelates with ISO 14155, the international standard for clinical investigations. (*note the course is based on the FDIS 18969 to be published in the fall 2026)

Rather than treating clinical evaluation as an isolated regulatory activity usually limited by many to the writing of a CEP and CER, this course demonstrates how it should be seamlessly integrated throughout the entire product lifecycle—from design and development to risk management, clinical investigations, regulatory strategy, reimbursement, and post-market clinical follow-up (PMCF).

By the end of the course, participants will be able to:

• Develop a strategic, lifecycle-based approach to clinical evidence generation.
• Understand how clinical evaluation drives decision-making across R&D, risk management, regulatory affairs, reimbursement, and post-market activities.
• Determine the level of clinical evidence required to support safety, clinical performance, effectiveness, and clinical benefit claims.
• Identify and critically assess existing clinical data to determine whether additional evidence is required.
• Design appropriate clinical investigation strategies based on available evidence and regulatory expectations.
• Select suitable study designs—from pilot and pivotal studies to post-market clinical investigations.
• Define meaningful study objectives, endpoints, and operational measures that generate scientifically robust clinical evidence.
• Understand the key success factors for planning and conducting high-quality clinical investigations.

Course Content

This interactive 2-day course, delivered in English, combines expert presentations with practical case studies and real-world examples, allowing participants to immediately apply the concepts learned.

Day 1 – Building the Foundation for Clinical Evidence

Discover how clinical evaluation supports product development from the earliest stages and becomes the backbone of an effective clinical evidence strategy.

Topics include:

• Integrating clinical evaluation into product development and risk management
• Identifying and assessing available clinical evidence and state-of-the-art information
• Evaluating medical and non-medical alternatives
• Critically appraising available data and drawing meaningful conclusions
• Collaborating effectively across R&D, regulatory, clinical, quality, and post-market functions throughout the device lifecycle

Day 2 – From Clinical Evaluation to Successful Clinical Investigations

Learn how to translate clinical evidence gaps into well-designed clinical investigations that generate not only reliable and regulatory-compliant data but useful data for both users, payers systems and patients.

Topics include:

• Selecting the appropriate clinical investigation strategy (pilot, pivotal, and post-market studies)
• Using clinical evaluation as the foundation for study design
• Factors influencing study design and regulatory expectations
• Defining study objectives, endpoints, and success criteria
• Operationalizing endpoints to ensure meaningful data collection
• Developing effective post-market surveillance and PMCF strategies

Who Should Attend?

This course is designed for professionals involved in the planning, generation, assessment, or use of clinical evidence for medical devices, including:

• Medical device manufacturers
• Clinical affairs and clinical research professionals
• Regulatory affairs specialists
• Quality and risk management professionals
• R&D and product development teams
• Clinical investigators and healthcare professionals
• Consultants supporting medical device development, clinical evidence generation and market access

Whether you are new to clinical evidence generation or looking to strengthen your strategic understanding of the latest ISO standards, this course will provide practical knowledge and immediately applicable tools to support successful product development and regulatory compliance.

Trainer

Danielle Giroud, CEO, World Medical Device Organization and
CEO, MD-CLINICALS, convenor of TC 194 WG 4 (ISO 18969 and ISO 14155)

What previous participants said (Fall 2024)

"Based in the Danilles solid experience, she was able to put things in context and she was able to provide a solid answer to every questions raised at the course. You could feel her passion for the clinical field"

"The speaker is very skilled"

"Danielle Giroud was very present, engaged and used her slides as backup but did not just read them. She had many examples and was open for questions which she used as examples"

"Good overview presentations with many relevant and interesting examples from real life"