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Biological Evaluation of Medical devices, Biocompatibility of Materials and Process

Picto Training Biological Evaluation of Medical devices and BiocompatibilityPrinciples 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

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Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

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