Course description
Fundamentals of Biocompatibility
Within medical devices, biocompatibility assessments are essential in the early stages of development to safeguard patient safety. Notified Bodies must see adequate data on biocompatibility (in accordance with ISO 10993) to be sure a device is biologically safe.Over four weeks this course will provide you with a baseline understanding of key requirements under ISO 10993 and what you need to include in an evaluation to ensure compliance. In addition, you will be able to understand biocompatibility in the context of risk management, and safety requirements under the Medical Device Regulation (MDR) and from a global perspective, cemented by a series of case studies.
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Suitability - Who should attend?
This course will be useful for anyone new to biocompatibility for medical devices, who would like a refresher of this material or to update their understanding of regulations, including:
- Regulatory Affairs
- Quality Assurance
- Manufacturing, development and design
- Toxicology
- Process development
Outcome / Qualification etc.
- Understand the relationship between biocompatibility testing and ISO 14971
- Analyse ISO 10993-1 and its updates
- Explore material characterisation in its different forms
- Examine the MDR safety requirements in the context of biocompatibility
- Recognise the differences in the EU MDR and FDA 510(k) approaches
- Review the relevant End Points for Consideration
Training Course Content
- Module 1: Introduction to Biocompatibility
- Module 2: Risk Management
- Module 3: ISO 10993-1
- Module 4: Material Characterisation
- Module 5: MDR Safety Requirements
- Module 6: International Perspectives
- Module 7: End Points to Consider
Why choose PTI
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