FDA, Good Manufacturing Practices GMP, quality system QSR, ISO 13485 regulatory consultants manufacturing development device, drug, diagnostic, combination medical products, 510(k), PMA, IDE

Risk Management -
Discovery to Market

Effectively managing risk requires knowledge of technologies, products, clinical applications, markets, macro forces in industry, and commercial and regulatory constraints. Our risk management advice reduces the risk of failure and increases the probability of control, compliance, and profit. We help -

  • Establish a risk management framework covering products from discovery to market
  • Train staff on medical product risk assessment methods
  • Utilize risk assessment conclusions to -
    • Make risk-based decisions in validation studies, process monitoring, and final product testing
    • Inform deviation / discrepancy response
    • Make risk-based decisions in response to complaints and adverse event reports

Using tools and methodologies customized to each client's needs, The Tamarack Group helps identify and reduce risks, solve problems, and get results.

See our book on Risk Management !!