Biological Evaluation of Medical Devices
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 utilizing 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.
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Suitability - Who should attend?
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
- Recognize how extractables and leachables impact medical device safety
- Discuss the Japanese and Chinese requirements
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Reviews by course attendees
Average rating 4.5
My expectation were to understand the key steps of the processes and the challenges linked to each steps.
It has been fully accomplished! The training and the speaker were very ...
Very knowledgeable person, who knows how to involve the attendants and make the subject more tangible. The quizzes force you to rehearse, remember and also apply the information...
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...
The course was very insightful and gave me a better understanding of the process and required effort. Excellent and knowledgeable speaker.