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18 July 2012
TV SD PSB Learning
Introduction
Medical device manufacturers and practitioners operate in a heavily regulated industry. Thus, product safety, quality and efficiency are very important considerations when developing medical devices. This seminar explores the testing and evaluation aspects of medical devices, which includes biocompatibility, clinical evaluation, microbiology and chemical testing. A medical device or material for use in contact with the patients body must be able to perform the intended function without inducing significant rejection or adverse response. The compatibility of the medical device and material with biological tissues, cells and body fluids needs to be carefully assessed before the device or material can be put for clinical trials and placed on the market.
Seminar Overview
Biological Evaluation of Medical Devices Biocompatibility Testing as per ISO 10993 Series Biocompatibility Testing as per Other Technical Guidelines Clinical Evaluation Microbiological Testing to Meet Regulatory Requirements Microbial Testing for Environmental Monitoring
Seminar Outline
Time 8.30am Activities/Seminar Title Registration Biological Evaluation of Medical Devices Overview on Medical Device Regulations Guidance and Planning of Biological Evaluation as per ISO 10993 Identification of material and chemical characterization Identification and quantification of degradation products Testing of leachable substances Q&A Biocompatibility Testing as per ISO 10993 series Categorization of medical devices Test selection Sample preparation Coffee Break and Networking Biocompatibility Testing as per ISO 10993 series (cont) Technical Principles of Biocompatibility Tests Cytotoxicity, Sensitization, Irritation Systemic Toxicity (Acute and Repeated Dose) Genotoxicity Implantation Haemocompatibility Networking Lunch Biocompatibility Testing as per Other Technical Guidelines As per Japanese MHLW As per ASTM Standards and USP Methods As per Chinese SFDA Requirements Clinical Evaluation Q&A Coffee Break and Networking Microbiological Testing to meet Regulatory Requirements Bio-burden Sterility Testing Microbial Testing for Environmental Monitoring Questions and Discussion End of Program Speaker
9.15am
10.00am
Ms. Li Yang, Assistant Vice President, Chemical Centre, TV SD PSB Ms. Li Yang, Assistant Vice President, Chemical Centre, TV SD PSB Ms. Li Yang, Assistant Vice President, Chemical Centre, TV SD PSB Dr. Vincent Lam, Lead Auditor, TV SD PSB All speakers and participants
10.30am
11.00am
12.30pm
1:30pm
All information is accurate at the time of printing. TV SD PSB Learning reserves the right to make changes to the programmes and speakers due to unforeseen circumstances.
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