envelope  Contact us


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

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

Get a quote proposal


clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors.