Seminar on Biocompatibility and Related Testing for Medical Devices Meeting CE Mark, US FDA and other Regulatory Requirements

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

Who Should Attend

Manufacturers, Distributors, Consultants, Laboratory Technicians and Relevant Personnel in the Medical Device Industries.

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

Dr. Lin Jianhua, Vice President, Chemical Centre, TV SD PSB

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

2.30pm 3.00pm 4.15pm 4.30pm

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.

www.tuv-sud-psb.sg

About the Speakers

Dr. Lin Jianhua is currently TV SD PSBs Vice President of Chemical Centre. Her main responsibility is to manage the Chemical Centre which provides testing services for a wide range of industries such as life science, food, pharmaceutical, electronics and chemical-related industries. Since graduating from Jilin University, China in 1985 with a BSc, a Ph.D in chemistry and from Nanjing University, China and University of Hong Kong in 1991 respectively. In 1992, she was awarded the Alexander von Humboldt Research Fellowship and worked in Wrzburg University of Germany for two years. Following that, she joined former SISIR in Singapore in 1994, which merged with NPB to form PSB, and later became TV SD PSB. Dr Lin has many years of research experience in chemistry and testing experience in chemical and material related areas. Ms Li Yang is currently the Assistant Vice President in Chemical Centre, taking care of biocompatibility and toxicology testing services in TV SD PSB. Ms Li Yang holds a Master Degree of Science (Biology) from National University of Singapore and Master of Business Administration from University of Birmingham, United Kingdom. Ms Li Yang has 14 years of working experience in the area of biomedical research & development and commercialization. Dr. Vincent Lam is currently the Manager of Medical Health Services in TV SD PSB Malaysia. In this capacity, he oversees the auditing and compliance activities of medical device manufacturers who are certified by TV SD Product Service. Dr. Lam is trained as a Microbiologist and has over 18 years of experience in the medical device industry, participating primarily in quality assurance and regulatory affairs where he oversees the compliance positions of medical manufacturers.

TV SD PSB Learning
1 Science Park Drive Singapore 118221 Tel: +65 6778 7777 Fax: +65 6779 7088 Email: enquiries@tuv-sud-psb.sg www.tuv-sud-psb.sg