Biocompatibility Evaluation and ISO 10993 to Support Registration of Medical Devices and Biomaterials

מרצה: Dr. Shayne Gad

תאריך: יפורסם בהמשך
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 2,150 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 15017
שפת הקורס: אנגלית
על הקורס

The goal of this course is to enable you to develop and bring to market new medical devices faster, more efficiently and with less expense by giving you a practical working knowledge of biocompatibility and device development.
This course provides a comprehensive explanation of the non-clinical and early clinical development of medical devices and combination products, emphasizing the principles of biocompatibility testing and the assessment of device safety.  It describes the different types of toxicity studies in device development and explains the relationship between materials biocompatibility, clinical trial design, regulatory strategy and project management. 
Emphasis is placed on how toxicity studies are integrated into the multidisciplinary development plans of new devices and combination products, and how they affect development decisions.  Topics include regulatory affairs, U.S. FDA and European requirements, the new device review process and common regulatory errors.
A special feature is the use of the “510(k) Game” to provide practical experience in the process of early device development.  Participants are encouraged to introduce topics for discussion and to have personal conversations with the course directors

קהל היעד

People in biocompatibility testing, clinical, management and regulatory positions in medical device and biomaterials companies will benefit from this course.  It is especially valuable to young companies with limited development experience who are active in pre-clinical development.  The course allows scientists who have specialized in other areas of development to gain an understanding of biocompatibility studies.  Regulatory and managerial personnel involved with planning project management and creation of development and regulatory strategies will acquire a thorough working knowledge of device development

Biocompatibility Evaluation and ISO 10993 to Support Registration of Medical Devices and Biomaterials
התועלת שתופק

¨ Understand what defines a device and the essentials of the regulatory process for its approval.
¨ Understand what biocompatibility tests are required and how they are done.
¨ Know the underlying mechanisms for device:tissue interactions.
¨ Understand why tests fail and what to do about it

השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Medical Devices: Definitions, Categories, and Markets
  • Approaches to Safety Evaluation in Device Development
  • Physical and Chemical Properties of Materials
  • ISO 10993, FDA and Pharmacopeia Requirements
  • EU and MHW Requirements
  • Toxicological Manifestations, Mechanisms, and Endpoints
  • Defining the Biocompatibility Questions and Data Sources for Answers
  • Road Map to Testing
  • Sample Selection and Preparation
  • Special Case Devices & Diagnostics
  • Acute Systemic Safety Tests
  • Cytotoxicity
  • Pyrogenicity
  • Local Tissue Tolerance: Irritation
  • Hemocompatibility
  • Immunotoxicity
  • Implantation Studies
  • Genotoxicity
  • Subchronic and Chronic Toxicity Studies
  • Carcinogenicity
  • Reproductive & Developmental Toxicology
  • Sterility, Sterilization and Heavy Metals
  • Special Studies and Cases
  • Analytical Chemistry Considerations
  • Combination Products
  • 510(k)s
  • IDEs
  • PMAs
אודות המרצה

Dr. Shayne Gad

The principal of Gad Consulting Services, has more than 29 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, inhalation toxicology, immunotoxicology, and genotoxicology.
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