ComplianceOnline

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

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

Description

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

Instructor Profile:

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.

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