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Clinical & scientific skills

Biocompatibility / BRA (CSS17)


Description
The Basic Lecture is for anyone with interest in understanding the Biological Evaluation process according to ISO 10993-1:2018. The Advanced Training gives practical instructions on how to do the evaluation of the biological safety of a medical device, from the theoretical evaluation of its raw materials to the characterization of the extractable and leachable substances, including an introduction to the Toxicological Risk Assessment of these substances.
Content
  • Basic Training
  • Introduction - Biocompatibility 1h Introduction Webinar
  • Basic Lecture 1 - General aspects related to biological safety
  • Basic Lecture 2 - Selection of biological endpoints
  • CARAQA Biocompatibility Presentation- General Introduction
  • Assessment - Basic Biocompatibility
  • Training content
  • Advanced Training (for BRA authors)
  • Advanced Lecture (Chemistry) - Part 0 - General Aspects
  • Advanced Lecture (Chemistry) - Part I - Physical and Chemical Information
  • Advanced Lecture (Chemistry) - Part II - Chemical Characterization Testing
  • Advanced Lecture (Chemistry) - Part III - Toxicological Risk Assessment
  • Advanced Lecture 5 - Biological endpoint testing
  • Advanced Lecture 6 - Considerations about degradation & Nanomaterials
  • Advanced Lecture (Chemistry) - Part 0 - General Aspects
  • Advanced Lecture (Chemistry) - Part I - Physical and Chemical Information
  • Advanced Lecture (Chemistry) - Part II - Chemical Characterization Testing
  • Advanced Lecture (Chemistry) - Part III - Toxicological Risk Assessment
  • Advanced Lecture 5 - Biological endpoint testing
  • Advanced Lecture 6a - Degradation considerations
  • Advanced Lecture 6b - Nanomaterials
  • Advanced Training (ARCHIVE)
  • Case studies
Completion rules
  • You must complete the units "Assessment - Basic Biocompatibility"
  • Leads to a certificate with a duration: Forever
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