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
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).
Who Should Attend
Who should attend
The course 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.
