Ensure compliance with the ISO 10993 series of standards for the biological evaluation of medical devices, as it is well-established and expected by regulatory authorities worldwide.
In the European Union, compliance with these standards is crucial for meeting the essential safety requirements outlined in the Medical Device Regulation (MDR). Understanding and implementing a comprehensive risk management strategy for biological safety is therefore paramount.
This seminar offers essential guidance on effectively utilising the ISO 10993 standards and integrating a robust risk management approach into the biological evaluation process of medical devices. Participants will have ample opportunity to engage in interactive discussions with industry experts, gaining practical insights and best practices.
Attendees will emerge equipped with the knowledge and tools necessary to navigate regulatory requirements, mitigate risks, and ensure the safety and efficacy of medical devices in compliance with global standards.
Benefits of attending
- Understand biological risk management
- Clarify the requirements of ISO 10993-1
- Learn what endpoints need to be addressed in a biological risk assessment
- Establish how much chemical characterisation is necessary
- Explore the FDA’s approach to ISO 10993
- Comprehend the Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
- Recognise how extractables and leachables impact medical device safety
- Discuss the Japanese and Chinese requirements
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
- Introduction to biological evaluation
- Overview of biocompatibility
- ISO 10993 history and development / ISO 10993 structure and content
- Relationship between regulatory standards
- Impact of MDR
- Impact of Brexit
- Gap analysis of existing biocompatibility data
- Medical device categorisation for biological risk assessment
- Endpoints to be addressed in a biological risk assessment
- GLP requirements
- Lab selection
Day 2
- Physical and chemical characterisation
- Extractables and leachables testing - when and why?
- Use of QSAR
- Use of data sources to and literature searching
- Change management
- International requirements
- Gas pathway devices
- Practical exercise
Who Should Attend
The event will be of particular importance to those in the medical device industry from the following departments:
- Regulatory affairs
- R&D
- Product safety/toxicology
- Analytical chemistry
- Risk assessment and risk management
- Materials research and evaluation
It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.
