Biocompatibility Evaluation and Risk Assessment of Medical Devices
to Current ISO 10993 2018

הרשמה מוקדמת במחירים מוזלים
הרשמה מוקדמת עד ה-26 בדצמבר 2019
3,700 ש"ח + מע"מ
הרשמה החל מה-27 בדצמבר 2019
4,300 ש"ח + מע"מ
מרצה: Dr. Shayne Gad

תאריך: 27, 28 ינואר 2020
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 20017
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 Risk Assessment of Medical Devices 
to Current ISO 10993 2018
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
  • Toxicological Manifestations, Mechanisms, and Endpoints
  • Defining the Biocompatibility Questions and Data Sources for Answers
  • Sample Selection and Preparation
  • Special Case Devices & Diagnostics
  • Acute Systemic Safety Tests
  • Cytotoxicity
  • Risk Assessments and (Q)SAR
  • Local Tissue Tolerance: Irritation
  • Hemocompatibility
  • Immunotoxicity
  • Implantation Studies
  • Genotoxicity
  • Subchronic and Chronic Toxicity Studies
  • Carcinogenicity
  • Reproductive & Developmental Toxicology
  • Heavy Metals
  • Special Studies and Cases
  • Analytical Chemistry Considerations
  • 510(k)s
  • PreSub Meetings
  • PMAs
אודות המרצה

Dr. Shayne Gad

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. (U of T at Austin, Pharmacology/Toxicology, 1977), DABT, is the principal of Gad Consulting Services, a twenty-eight year old consulting firm with ten employees and more than 600 clients in the US and overseas.
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