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Understanding Biocompatibility of Medical Devices

Date: May 3, 2018

Time: 12:30 pm - 4:15 pm

Location: North Ryde / Macquarie Park, Sydney

Topics will include:

  • Chemical characterization including extractables and leachables testing
  • Toxicological risk assessments
  • Biocompatibility testing
  • Pitfalls to avoid while developing testing plans
  • Future trends for combination products
  • Implications of new FDA guidance on the use of ISO 10993-1

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Current Test Strategies & Practical Implementation of the Changes of ISO 10993

Date: June 12-13, 2018

Time: June 12 - 8:15 am to 6:00 pm or June 13 - 8:15 am to 4:30 pm

Location: Fürstenried Castle / Munich

Cost: 1 Day - €620 +tax or 2 Days - €890 +tax

Topics will include:

  • Biocompatibility Testing: Introduction
  • Extractions According to ISO 10993-12
  • Chemical Characterization (ISO 10993-18) and Degradation Studies (ISO 10993-13)
  • Toxicological Risk Assessment in Chemical Characterization
  • Alternative Methods in Eye & Skin Irritation Studies (ISO 10993-2, ISO 10993-10)
  • In Vitro Methods in the Evaluation of Skin Sensitization Potential
  • Hemocompatibility Testing in the 21st Century According to ISO 10993-4
  • Systemic Toxicity & Implantation (ISO 10993-11, ISO 10993-6)
  • Knowledge Deepening & Practical Experience

This seminar is intended to prepare our client for changes to ISO 10993. This seminar will be held in German, with materials provided in English.

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View our past seminars

Changes in Europe's Medical Device Regulations: Consequences for Manufacturers

Peter Diesing, Ph.D. Head of Certification, Eurofins Medical Device Testing

Developing Test Strategies Per the New ISO 10993-1: Current Status & Upcoming Changes

Hana Hofman-Huether, Ph.D., Head of Consulting, Toxicology, Eurofins Medical Device Testing

Chemical Characterization: The Starting Point for Biological Evaluations
Hannah S. Tims, Ph.D., Senior Chemist, Eurofins Medical Device Testing

Biocompatibility Basics: Making Sense of the Annex A Matrix
Odete Mendes, Ph.D., Director of Toxicology & Pathology,Eurofins Medical Device Testing

Developing a Testing Plan for Medical Device Design Verification
Stephen Spiegelberg, Ph.D., President,Cambridge Polymer Group, Inc.

Endotoxin Testing: Make Sure FDA's New Guidance Doesn't Delay Your Product Launch
Tami Benjamin,Director, Microbiology, Eurofins Medical Device Testing