Design for Six Sigma in Medical Devices: Integration with the FDA Quality Systems Regulations

This Six sigma training in Medical device will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device. Design for Six Sigma (DFSS) can be used to design, manufacture and sell high quality, defect-free, safe, effective devices that meet the intended use while also generating healthy profit margins for the company.

This webinar will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device. Risk assessment at every stage of the process is also a fundamental aspect of the process. The presentation will also show how the DFSS process helps companies to comply with the ISO 13485 and the FDA quality systems regulations for medical devices.

Areas Covered in the seminar:

• The Design for Six Sigma philosophy and its incorporation into new product development
• Design for Six Sigma and New Product Development with reference to medical devices from concept to commercialization
• Translating intended use requirements to quantifiable product specifications
• Finding quantifiable relationships between product design, critical parameters, and process controls to product performance
• Evaluating product capability internally and externally
• Mapping the Design for Six Sigma methodology to the FDA 21CFR Part 821 and the ISO 13485 requirements
• The value of risk assessment in the Design for Six Sigma process

Who Will Benefit:

• This webinar will be of value to all those involved in new product development, quality and FDA/ISO regulations
• Business managers
• Technology/engineering
• Manufacturing managers
• Quality managers
• Regulatory
• Sales and marketing