ISO 14971: Understanding and Applying Risk Management

Why Should You Attend:

Understanding risk management in medical devices is a must do for any professional serving medical industry in any format. It tends to improve product reliability and durability and by that minimize warranty costs, recalls, bad press and more. ISO 14971 promotes good practices and processes necessary to ensure proper risk management is put in place - and it is effective.

During this 120-minute session, the presenters - Jasmin NUHIC and Salim Khan - will share their experiences and insight gained from implementing risk management processes in medical device companies. You will learn from real-life examples, as well as from the research they have conducted in the area of risk management for medical devices. The discussion will be highly interactive and participants can ask specific questions related to the company/environment they serve.

Areas Covered in the Seminar:

• FDA and ISO 14971.
• Risk Management Process.
• Risk Analysis.
• Risk Evaluation.
• Risk Control.
• Overall Residual Risk Evaluation.
• Production and Post-Production.
• Questions and answers and give opportunity to ask specific questions related to the company/environment you serve.

Who Will Benefit:

• Product development engineers
• Quality Engineers
• Quality Managers
• Internal and External Quality Auditors
• Management Representatives
• FDA inspectors
• CAPA investigators
• Project managers
• Consultants
• AdvaMed companies

Instructor Profile:

Jasmin NUHIC - Professional with proven record of leading teams that deliver projects in full scope, below a budget and ahead of schedule through process optimization, business growth and talent development. Over 12 years of experience in FDA regulated industry with vast experience in operations, quality management systems, manufacturing, concurrent engineering, program management and information systems. Positive and verifiable track record in continuous improvement and cost saving initiatives through use of lean sigma and six sigma methodologies.

Salim Khan - holds a master degree in Manufacturing Engineering, an MBA and BS in Mechanical Engineering. He is also ASQ certified Six Sigma Black Belt, Certified Reliability Engineer, Certified Quality Engineer. Salim has successfully implemented several design control and risk management processes for medical device companies. He also has extensive experience in developing efficient product development process. He enjoys statistics and has completed several process validations.

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