This course provides a practical overview of the chemical characterization and toxicological risk assessment of medical devices in accordance with ISO 10993-18:2020 and ISO 10993-17:2023. Participants will learn how to plan and interpret Extractables & Leachables (E&L) studies, define extraction strategies, assess toxicological risks, and meet current biocompatibility requirements in both EU and US regulatory frameworks. The training combines scientific principles with practical regulatory expectations to support robust biological safety evaluations and compliance activities.
Participants will be eligible to request a complimentary 30-minute consultation with our experts.
At the end of the course, participants will receive the course slides and a Certificate of Competence.
This course is intended for medical device manufacturers, medical device designers, Regulatory Affairs professionals, Quality Management System (QMS) and Quality Assurance professionals, clinical engineers, and biomedical engineers involved in biocompatibility assessments, chemical characterization, toxicological risk evaluation, and regulatory compliance activities.
€750 + VAT
10% discount for registrations completed by 30 July 2026
5% discount for registrations completed by 30 August 2026
10% discount on the second registration from the same company