Biocompatibility Evaluation and Risk Assessment of Medical Devices to Current ISO

Conducted by: Dr. Shayne Gad

Categories: Bioforum International, Medical Devices

SKU: 20017

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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.

Dates:

27/01/2020
28/01/2020

Course location: Kfar Maccabiah, Ramat Gan

Duration: 2-Days Course

Hours: 09:00 - 17:00

Credits: 2

Course Language: עברית

Course price: ₪4,860 + VAT

Early registration is Closed

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Issues to be covered

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

Who should attend

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.

Benefits to the Participants

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

About The Lecturer

Shayne Gad

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970)