ISO 10993: Biocompatibility from Concept to Practical Approach
ISO 10993: Biocompatibility Overview
This one-day training will focus on the concept of Biocompatibility, and application of ISO 10993, part 1.
From concept to practical approach of ISO 10993, this training will provide insights into how the standard is to be applied, what are the requirements for a valid test report, and what is the expectation of the Notified Body when it comes to the documentation of biocompatibility testing:
Course Content to Cover:
- The concept of Biological Safety
- The value of ISO standards compared to guidelines and European Directives
- Get aquainted with ISO 10993 part 1 (classification of medical devices, sample identification and preparation, test documentation)
- Practical Approach 1: Establish and discuss test plans for several medical devices
- Practical Approach 2: Evaluating the validity of a test report
- And more.
Who Should Attend:
Experts from Regulatory Affairs, Research & Development, Quality or professionals involved in implementing, maintaining and auditing quality management systems in a medical devices manufacturing environment.
About Our Subject Matter Experts:
Our instructor, Professor Dr. rer. nat. Dr. med. habil. Sabine Kloth is an expert with an impeccable track record and numerous years of experience in both industry and product compliance.
Since 2004 Professor Kloth has been Professor for Anatomy at the University of Regensburg in Germany. The main focus of her current lectures: Regenerative Medicine.
Scientific background and main research interests include: Kidney organogenesis and regulation of blood vessel formation.
Since 2004 Professor Kloth has been affiliated with TÜV SÜD Product Service GmbH as Senior Product Specialist for Medical Devices Utilizing Material of Animal Origin. She is responsible for consultation procedures including TSE-consultation acc. the Directive 2003/32/EC and for consultations for medical devices including human blood or its derivatives.
Professor Kloth is a member of the TSE/BSE Working Group of the EU Commission, and a member of ISO standardization committees with focus on Biological Safety and Cell-Based Medical Products. She is convenor of Working Group 1 of ISO TC194 SC1 with the main topic of risk management for biological materials.
Before joining TÜV SÜD Product Service GmbH Professor Kloth was CSO in a tissue engineering company aiming to produce implantable autologous blood vessels in vitro.
Lunch and training materials will be provided.
Hotel Information
This one-day training will be held at The Hampton Inn, Shoreview, MN. For more information on accomodations, contact Hampton Inn at 651-482-0402, and ask for the special room rate for TÜV SÜD America, or register online.
Scheduled Dates:
Cost: $299.00 (USD)
Time: 8:00 am - 5:00 pm CST
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I would like to register!
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Questions? contact:
Kelly Nguygen
TUV SUD America Inc.
651-604-3382
knguyen@tuvam.com |
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Cancellation Policy
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