Risk Management for Medical Device – Virtual Course

DETAILS (Return to Main)

Who Should Attend

• Quality managers, quality engineers and quality technicians involved in the development and manufacture of medical devices. 
• Professionals directly involved in meeting the FDA’s Quality System requirements such as those in regulatory affairs, quality assurance, process development, or manufacturing. 
• To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of Quality System regulation, including direct work experience.

Learning Outcomes

Upon completion, attendees will be able to:

• Identify and analyze hazards of product, process or service
• Create a process map
• Perform fault tree analyses
• Perform failure modes and effects analyses
• Perform hazard analysis and critical control points
• Understand and analyze software hazards
• Understand basics of human factors and its relationship to risk management
• Begin performing risk management in your company

Market Focus:

• Research and development, manufacturing and field service (medical device and other regulated industries).
• The material will also apply to other industries and processes such as aerospace, electronics, healthcare and so on.

Related ASQ Bodies of Knowledge:

Many of the statistical techniques are covered in the CQE, CRE, and CSSBB bodies of knowledge. There will also be some interest or linkage to HAACP certification.

Return to Main