Biological Evaluation of Medical devices, Biocompatibility of Materials and Process

Principles of ISO 10993-1

• The relation between the ISO 10993-1 and the essential requirements of MDD 93/42/EEC
• Other standards involved for the ISO10993-1 Implementation.
• Input data of the ISO10993-1 Application

Approach and Methodology according to ISO 10993-1

Elements to take into account for the Product Assessment

• Definition of Material or finished product for the Pre-Clinical Evaluation
• Classification of Medical Devices
• Biological Assessment Process
• Biological Testing / Pre-clinical Testing
• Biological Technics :Methods and Analytical Technics
• Chemical Technics :Methods and Analytical Technics

Approach of Risk Management Process for Medical Devices Biological Evaluation

• Biocompatibility of Materials & Biocompatibility of Processes
• Information on Post-Production, Feedback, and Materiovigilance
• Review of Scientific Literature: Methodology
• Review of Scientific Literature: Recommendations
• Review of Scientific Literature: Preparation of the Report