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Wed Apr 18
  • Seminar

UL LIVE SEMINAR: Biological Safety Evaluation and Packaging Testing for Medical Devices

  • Seminar

Haribabu S., Toxicologist & Subject Matter Expert and Kushalappa.M.D, Project Engineer will be conducting a free seminar on Biological Safety Evaluation and Packaging Testing for Medical Devices on April 18, 2018.

Course Objectives:

  • Understand the principles governing the biological evaluation of medical devices based on risk management process.
  • Implement the strategy and stepwise approach to identify the biological end points Biological risk/safety assessment based on toxicological end points
  • Recent changes in the standards to fulfill regulatory requirements.
  • Medical devices categorization based on Nature of contact Duration of contact Biocompatibility test methods based on ISO 10993 standards
    • ISO 10993-Part 3
    • ISO 10993-Part 4
    • ISO 10093-Part 5
    • ISO 10993-Part 6
    • ISO 10993-Part 10
    • ISO 10993-Part 11
  • Packaging Testing for Medical Devices(ISTA 2 A and ISO 11607 Requirement)


Introduction to Biological Evaluation of Medical Devices

  • Introduction of ISO 10993
  • Biological Evaluation Steps
  • Role of Material Characterization
  • Toxicology risk assessment
  • Basic three biocompatibility tests
  • Sub-acute, chronic toxicity, Implantation
  • Genotoxicity
  • FDA recommended end points
  • Role of Sample preparation and extraction


Packaging Testing for Medical Devices(ISTA 2 A and ISO 11607 Requirement)

  • Key terms and definitions
  • Simulation of life cycle of a medical device
  • Typical life cycle
  • Regulations and Standards
  • Packaging validation test -ISTA 2 A (International Safe Transit Association)
  • Package Integrity Test
  • Shelf-life study design


Who Should Attend?

  • Medical device manufacturers
  • Raw material suppliers
  • R&D scientists
  • Quality assurance managers
  • Regulatory affairs managers
  • Packaging material manufacturers
  • Packaging material suppliers


Course Fee: Free on invite basis (limited seats).

Where: UL Quality Assurance Pvt. Ltd, A-12, Infocity 1, Sector-34, Gurugram-122001.

Click the link to register: http://connect.ul.com/Biocomp-Packaging-Gurugram_LP-Reg.html

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