Course overview
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 course 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.
CPD Hours: 12
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
Speakers
Annette Callaghan
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
