Biocompatibility assessments are an essential part of submissions to regulatory agencies for medical devices. This course will provide you with a solid understanding of the principles behind crucial regulations and issues within biocompatibility.
Supported by a wealth of examples and two practical sessions, this course will give you an in-depth look at ISO 10993. Over two days, you will examine the biological evaluation process and will improve your understanding of testing end-points and testing alternatives.
Suitability - Who should attend?
This course will be useful for anyone new to biocompatibility for medical devices, or who would like a refresher of this material, including:
- Regulatory Affairs
- Quality Assurance
- Manufacturing, development and design
- Process development
Training Course Content
- Understand how biocompatibility and biological safety have developed
- Comprehend the core structure and content of ISO 10993
- Learn how to categorise devices for biological evaluations
- Understand how to use the Annex A.1 table to identify end-points
- Examine materials characterisation
- Consider when in-vivo testing may be necessary
- Review sterilisation options
- Investigate global requirements
PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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