Training #06

Perform a biological risk assessment for medical devices in line with the current ISO 10993-1 standard (Biological evaluation of medical devices - Part 1: Evaluation and testing as part of a risk management process).

• Post-training evaluation questionnaire
• Training satisfaction evaluation questionnaire

Each participant will be able to :

• Identify the key parameters of the biocompatibility of a medical device
• Establishing the biocompatibility strategy of a medical device
• Establish a biological risk assessment plan
• Plan the tests to be carried out to ensure the biocompatibility of a medical device
• Prepare a biological risk assessment report

• Detailed training schedule
• Digital training materials
• Training evaluation questionnaires
• Results of trainee learning assessment
• Training certificate

• Normative and regulatory context
• General principles of the current ISO 10993-1 standard
• Categorization of medical devices
• Data collection: physical, biological information, review of scientific literature on materials, etc.
• Chemical characterization and biological tests
• Plan with the laboratory the physicochemical characterization tests to be carried out according to the current ISO 10993-18
• Introduction to the assessment of permissible limits according to the current ISO 10993-17
• Data analysis and biological risk assessment
• (Toxicological risk analysis)

Starting at €980
Price adapted to your needs, number of participants and type of training (inter / intra-company).
Contact us for a personalized quote

• Teaching aids (course support presentation, extracts from standards documents, document templates, etc.)
• Practical exercises, feedback, case studies based on your system