Safety Assessment for Medical Devices and Combination Products

מידע כללי
משך הפעילות: 3 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 5,850 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 17804
שפת הקורס: אנגלית
על הקורס

The aim of this course is to review the principles of testing materials for biocompatibility. The full range of test methods will be discussed including chemical analysis, cell culture, and other in vitro methods, acute animal studies including USP methods, thromboresistance, sensitization, long-term implant and other special studies. The nature of polymers and the sources of incompatibility will be discussed along with specific examples. Methods of testing will be related to the end use of a product. Examples of recommended testing programs will be presented, as well as the impact of FDA’s Good Laboratory Practice regulations and ISO requirements on preclinical testing of materials and medical devices. 

קהל היעד

This course is intended for professionals who have responsibilities for the safety and marketing approval of medical devices and drug/device combination products. It will be especially valuable to:

  • Scientists
  • Engineers
  • Biologists
  • QA/QC
  • Manufacturing personnel
  • Regulatory affairs

These individuals may come from industrial, government, academic and/or contract testing facilities. The course should be especially useful for those newly assigned to product safety responsibilities although it also provides an opportunity for more experienced personnel to update their knowledge.

Safety Assessment for Medical Devices and Combination Products
התועלת שתופק

Course Topics Include:

  • Principles of Testing Materials
  • Products for Biocompatibility and Safety
  • Regulatory Requirements for Development
  • Marketing Approval of Medical Devices
  • The Impact of FDA’s GLP Regulations
  • ISO Requirements    
  • Regulatory Path to the Clinic and Market
  • Combination Products
  • Leachables and Extractables

Learning Objectives:
Upon completion of this course, you will be able to:

  • Explain both the nature of materials used in medical devices and of any associated drugs and their potential for causing adverse reactions
  • List the methods for devising a sound safety evaluation program
  • Outline the specific testing protocols for testing materials in vitro and in vivo
  • Describe the significance of Good Laboratory Practice regulations for preclinical testing of materials
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

Review of Learning Objectives
Medical Devices:

  • Definitions: Medical Devices and Combination Products. Categories & Markets
  • Approaches to Safety Evaluation in Combo and Devices Development: Who Regulates FDA/EMA/CFDA/MLHW
  • Data Mining: Utilizing Prior Art in Study and Program Design

Regulatory Requirements:

  • Current FDA, ISO, CE Mark and Pharmacopeia Requirements
  • ICH Requirements


  • Toxicological Manifestations, Mechanisms and Endpoints
  • Road Maps to Testing (ISO 10993-1 and ICH M3 (R2))
  • The CMC section: Physical and Chemical Properties of Materials
  • Sample Selection and Preparation (ISO-10993-12)
  • When the Drug Component is the Principal Mode of Action in a Combination Product
  • Acute Systemic Safety Tests (ISO-1093-11)
  • Cytotoxicity (ISO-10993-5)
  • Hematocompatibility (ISO-10993-4)
  • Local Tissue Tolerance: Irritation & Pyrogenicity (ISO-10993-6), (ISO-10993-10)
  • Immunotoxicity (ISO-10993-20)
  • Genotoxicity (ISO-10993-3)
  • Implantation Studies (ISO-10993-6), (ISO-10993-8)
  • Subchronic and Chronic Toxicity Studies Under the New FDA Interpretation
  • Reproductive & Developmental Toxicology (ISO-10993-3)
  • S11-Juvenile Toxicity

Special Case Devices: Respiratory, Cardiovascular, Dentistry and More

  • Carcinogenicity (ISO-10993-3)
  • Toxicokinetics for Medical Devices (ISO-10993-16)
  • Contracting Studies to Outside Laboratories
  • Risk Assessment for Medical Devices (EN 14971)
  • Safety Considerations for Combination Products
  • Leachable and Extractable (L&E) Studies and Associated Risk Asessment
  • Leachable and Extractable Studies and Notified Bodies (EU) and the SFDA (China)
  • Special Studies
  • Clinical Safety Trials and Epidemiology Studies for Medical Devices
  • FDA Regulatory Submissions: IDEs, INDs, 510(k)s and 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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