envelopecontact us

phone1-301-495-0477

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

Training Application Form

* Required field






combo ISO 13485 9001

Questions?

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

   1-301-495-0477

lne gmed arrow Submit a request

clientsWe're Hiring!

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

Don't have an account yet? Register Now!

Sign in to your account