Risk Management for Medical Devices: ISO 14971:2007

Duration: 60 Minutes
The company is required to implement a risk management program as an integral part of its quality system. A robust risk management program identifies and manages hazards throughout the product lifecycle. Once identified, hazards must be eliminated or mitigated to achieve the highest possible level of product safety and effectiveness. The company depends on its risk management program to continuously monitor and evaluate potential hazards associated with its products, and to take appropriate actions designed to lower the probability of harm to stakeholders.
ISO 14971
Instructor: Ron Schoengold
Product ID: 500025
Key Points Covered:
  • Regulatory Framework
  • Definitions
  • Risk Management Process
  • Risk Modeling
  • Risk Management Plan
  • Risk Analysis Tools
  • Risk Management Training Requirements
  • Risk Management Report
Objectives of the Presentation:
  • Understand how to manage risk to promote product safety and effectiveness
  • Comply with current standards and regulations
  • Make better project management decisions
  • Provide exposure to basic risk modeling tools
  • Promote customer confidence
Who can Benefit:
  • Quality Managers
  • Regulatory Managers
  • Program Managers
  • Project Managers
  • Product Development Managers
  • R & D Managers
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  • Get certification of attendance.
$375
Recorded Session for one participant
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Instructor Profile:
Ronald Schoengold is a consultant to the biotechnology, pharmaceutical and medical device industry. He is a certified regulatory affairs professional and Fellow of the Regulatory Affairs Professional Society. Ron provides advice on quality, regulatory and product development issues, helping businesses effectively commercialize and maintain their products and services. He has been an active contributor to the industry for over 45 years and has developed commercially successful pharmaceutical, screening and diagnostic products for GI medicine, infectious disease and point-of-care testing. Ron is also an advisor to the Larta Institute, an NIH supported group that assists young companies who receive SBIR grants. He has published scientific journal articles and presented seminars and webinars on scientific and current regulatory compliance topics. Ron also co-authored a book chapter on point-of-care testing and holds 8 patents related to point-of-care diagnostics. He earned his bachelor’s degree in biology and chemistry, did his master’s training in microbiology and biochemistry, and completed additional graduate studies in microbiology, genetics, molecular biology and immunology.
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