Instructor:
Ronald Schoengold
Product ID: 700132
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:
Areas Covered in the Webinar:
Who Will Benefit:
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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