Design for Six Sigma in Medical Devices: Integration with the FDA Quality Systems Regulations
Instructor:
Vinny Sastri
Product ID: 700139
Training Level: Advanced
- Duration: 60 Min
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
Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.
More Training By Experts
- Designing in Quality via Statistical Process Control
- Design Controls Basics - From Design Inputs to Design Outputs and Effective Design Transfer
- Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management
- What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained
- Test Method Validation Basics - Ensuring Adequacy and Reliability of Your Test Methods
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