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Biological Evaluation of Medical Devices

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Regulation and quality assurance are significant and integral parts of medical devices development processes. In order to keep you updated in the latest, most important aspects of both regulatory rules and quality assurance, we offer a series of conferences and seminars to assist you in your path towards being approved by the FDA, CE, ISO and other regulatory bodies. 

Our next comming conference will take place in Tel Aviv Israel:

Biological evaluation of medical devices 
November 16th, 2017 

Leonardo City Tower Tel Aviv Hotel

The following subjects will be discussed in the conference: 

  • 10993 standard series: approaching bio-compatibility within a risk management process 
  • Introduction to the new FDA guidance 
  • Chemical characterization of the materials: what does it means in practice 
  • Toxicological assessment (ISO 10993-17) application in order to evaluate obtained data from chemical chemical characterization 
  • Bridge approach and change management optimization thanks to chemical characterization 
  • Bio-compatibility tests overview
  • What’s new in ISO Technical Committee 194 “Biological and clinical evaluation of medical devices”: an update from October 2017 meeting in Seoul 

More info & registration