On demand training: Biological Safety and Risk Management of Medical Devices. EU MDR, FDA, and ISO 10993‑1:2025 in Practice

The course begins by covering the fundamentals of biocompatibility, the relationship between the MDR and ISO 10993‑1, and the roles of key authorities such as the EMA, FDA, and Notified Bodies. It also explains the evolution of ISO 10993‑1 towards a risk-based approach.

In addition, the course includes further opportunities for interaction and learning, such as a 30-minute consultancy session with an expert, a live sessions with Q&A, direct access to experts via email (“Ask the expert”), and access to further readings, previous webinars, and supplementary materials.

At the end of the training, you will receive information about the timing and how the consultany session and the live session will be delivered

Location and Language

• Location: Online, E-Learning Content
• Language: English

Key Topics

• Module I- Bridge Between EU Legal Requirements and ISO Technical Requirements 
• Module II – Novelties Introduced by ISO 10993-1:2025 
• Module III – Biological Risk Management (Part 1): Biological Risk Analysis 
• Module IV-Biological Risk Management (Part 2): Risk Evaluation and Lifecycle Management 
• Module V – Biological Evaluation Plan (BEP), Testing and Biological Evaluation Report (BER) 
• Module VI – FDA Requirements and Common Pitfalls

Expert

• Daniele Lioi, Medical Device Senior Consultant and Business Unit Manager

Registration Fees

€350 instead of €490.
Starting in September, the price will increase to €415. At the end of the launch promotion period, the standard fee of €490 will apply.

Please note that all prices shown are excluding VAT.

Click here to access the Online Course