On Site Training: ISO 10993-1:2025 – Key Updates, Regulatory Impact, and Changes in Medical Device Biological Evaluation

This course provides a comprehensive overview of the updated ISO 10993-1:2025 and its impact on the biological evaluation of medical devices. Participants will learn how to apply risk management principles to biocompatibility assessments, interpret regulatory expectations under the EU MDR and US FDA frameworks, and effectively plan, conduct, and document biological evaluations throughout the device lifecycle. The training covers Biological Evaluation Plans (BEPs), Biological Evaluation Reports (BERs), biocompatibility testing strategies, chemical and physical characterization, management of unexpected test results, and interactions with regulatory authorities and notified bodies. Practical examples and case studies will support the application of key concepts in real-world regulatory scenarios.

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.

Location and Language

• Location: Eurofins Biolab, Via Bruno Buozzi 2, 20055 Vimodrone (MI), Italy
• Language: Italian

Key Topics

Module I: Regulatory Framework and ISO 10993-1:2025 Updates

• Biocompatibility requirements under EU MDR and US FDA regulations
• Overview of ISO 10993-1:2025 and key changes introduced
• Relationship between biocompatibility and risk management according to ISO 14971
• Biological risk assessment throughout the medical device lifecycle

Module II: Planning and Conducting Biological Evaluations

• Structure and key elements of a Biological Evaluation Plan (BEP)
• Medical device categorization and identification of relevant biological endpoints
• Identification, estimation, and control of biological risks
• Gap analysis and assessment of existing data
• Chemical and physical characterization strategies
• Overview of key biocompatibility tests
• Sample preparation considerations
• Managing unexpected biocompatibility test results
• Development of a Biological Evaluation Report (BER)
• Practical examples and case studies

Module III: Regulatory Interactions and Expectation

• Responding effectively to questions from competent authorities
• Notified Body expectations, common observations, and non-conformities
• FDA expectations and feedback examples
• Regulatory case studies and lessons learned

Who Should Join?

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, biological evaluation, product safety, and regulatory compliance activities.

Speaker

• Martina Danesi, Senior Medical Devices Consultant, Eurofins Regulatory & Consultancy Services

Registration Fees

€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

Click here to register