Generating Clinical Evidence for Medical Devices using 14155 and ISO 18969
In this course you will learn the integrated approach of the clinical evaluation process and its important links with risk management, R&D, clinical investigations, regulatory, reimbursement and post market clinical follow up.
Purpose and outcome
Clinical evaluation is a critical part not only of product validation but should play an important role throughout the full product lifecycle. This is the approach that the new ISO 18969 takes and is being received at this early stage in a very positive manner by many stakeholders including notified bodies.
Content
In this course you will learn the integrated approach of the clinical evaluation process and its important links with risk management, R&D, clinical investigations, regulatory, reimbursement and post market clinical follow up. The moto is breaking the silos, but that is easier said than done. Participants will acquire a practical and in-depth understanding of the integrated approach and are guaranteed to bring important messages back to the office to work on the integrated approach that will contribute to not only efficiency but better chances in getting a fast-track with their notified bodies as they will have it right!
Furthermore, the link between clinical evaluation and clinical investigations at the level of strategic development of the clinical development plan will be covered in depth providing a valuable input on how to plan the clinical investigations efficiently. An overview of the latest changes of ISO 14155 will also be covered in this course.
Practical examples will be provided on how to prepare a clinical strategy for Europe, while also integrating the requirements of other geographic regions – such as the US, China, and ASEAN countries – into a global strategy.
The course will be conducted in English, alternating between lectures and studies.
Who should attend
This course is targeted towards medical writers, clinical project managers, clinical research associates and others working in the field of clinical investigations of medical devices including new notified body clinical reviewers and regulators.
Trainer
Danielle Giroud
CEO, World Medical Device Organization (WMDO) and CEO, MD-CLINICALS; Convenor of ISO/TC 194/WG 4
Danielle Giroud is an internationally recognised clinical research and regulatory expert with more than 40 years of experience in the medical device industry. On this course, she shows how ISO 18969 and ISO 14155 can be used together to build a lifecycle-based clinical evidence strategy—from early product development and clinical evaluation to study design, clinical investigations and post-market activities. Drawing on her direct involvement in developing both standards, she helps participants identify evidence gaps and translate them into scientifically robust and regulatory-compliant clinical strategies.
What previous participants said
Contact
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12-13. november 202613-14. maj 2027
11-12. november 2027
12-13 November 2026 - at 09:00 - 16:00
Price ex. VATLatest Registration
12.10.2026
Latest Cancellation
12.10.2026
Bøge Allé 5, 2. th
2970 Hørsholm
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Terms
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Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.