Risk Management for Medical Devices: ISO 14971:2007

Why Should You Attend:

Medical device companies are required to implement a risk management program as an integral part of their product development activities. Risk management assessment is utilized to manage hazards and potential hazards throughout the product lifecycle, and is required for regulatory compliance. Known hazards must be eliminated or mitigated to achieve the highest possible level of safety and effectiveness of the product for its intended use. Once a product is marketed, the company is also expected to maintain the risk management program, monitoring for new potential hazards and taking preventive action to lower the probability of harm to stakeholders.

Learning Objectives:

• Promoting product safety and effectiveness
• Making better project management decisions during product development
• Complying with current standards and regulations
• Overview of basic risk modeling tools
• Promoting quality and customer confidence

Areas Covered in the Webinar:

• Risk management regulatory framework and definitions
• Risk Management Process
• Risk Modeling
• Risk Management Plan
• Risk Analysis Tools
• Risk Management Assessment Training
• Risk Management Report
• ISO 14971 Gap Analysis Checklist

Who Will Benefit:

• Quality managers
• Design engineers, process engineers and manufacturing engineers
• Internal auditors
• Personnel or vendors developing medical device software
• Risk managers
• Medical device product managers

Instructor’s Profile:

Ronald Schoengold, has been an active contributor to the medical device, pharmaceutical and biomedical environment for over 45 years. As a consultant to both large and small companies, he offers expert advice on quality systems, regulatory submissions and resolution of regulatory and quality problems. He is also an experienced auditor in clinical research, supply chain and manufacturing (GMPs). Ron is certified in regulatory affairs and has a proven record of accomplishment for integrating quality and regulatory requirements with technical, organizational and business development needs. He offers critical advice on the effective commercialization, support and maintenance of medical products and services and is an advisor to the National Institutes of Health, Commercialization Assistance Program, assisting companies awarded SBIR grants. Ron has published, presented or contributed to more than 16 scientific publications including a book chapter on point-of-care testing. He holds 8 patents related to point-of-care diagnostics.

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