Paladin Medical offers customized training programs for our clients. The following are example topics. Contact Us for your customized training.

  • Medical Devices 101: Pre-market Requirements and Quality System Regulations +

    • Understanding basic premarket regulations
    • Core management and key personnel responsibilities through the product life-cycle


  • Biomaterials Use in Medical Devices +

    • How to select and qualify biomaterials
    • How to optimize existing information from literature and suppliers to reduce costs
    • Risk-based approach to ISO 10993 and ASTM standards testing
  • Clinical Trials +

    • Understanding the specific obligations for non-significant risk studies and IDE trials
    • Impact of poor protocol design on the outcome of the trial
    • How do ISO standards and US FDA Bioresearch Monitoring requirements for Good Clinical Practices differ?
    • Elements of a good sponsor-investigator agreement
    • Understanding the difference between study monitoring and data auditing
  • Design Control and Review +

    • Effective design and development planning
    • Understand the use of design review to facilitate decision making and documentation
    • Different requirements of QSR 820 and ISO 13485 for Design Review
    • Creating a well-organized Design History File and change control documentation
  • Risk Analysis and Risk Management +

    • Integrating design-level hazard analysis into Design Planning, Verification and Validation
    • Using a risk matrix to best effect
    • Leveraging ISO 14971:2006 and quality systems to optimize your CAPA program with management audits, trending, reporting, and risk mitigation as p[art of effective risk management
  • Good Laboratory Practices +

    • Understanding how Good Laboratory Practices are critical for pre-clinical studies when GLP is not appropriate
    • What sponsors of GLP studies need to know about the QAU, reporting and archiving
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