Medical Device Supplier Quality Management - Webinar CD/Transcript

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Medical Device Supplier Quality Management

Purchasing controls and supplier management continue to be target-rich environments for FDA investigators.

And to make things more complicated, the ISO 13485:2016 standard was released and you must make sure your supplier quality procedures are compliant with these new standards.

In order to avoid citations you need to ensure your supplier quality related procedures are compliant with ISO 13485:2016 and Part 820.50. Without guidance you can be in for plenty of headaches and complications.

Join expert Jim Shore — Director of Quality at Titan Medical, Inc. — for an overview and up-to-date information on purchasing controls for quality assurance and control of purchased components, services or finished medical devices.

This session will cover the top three supplier controls changes you need to make this year including:

  • Performing a gap assessment to the new ISO Requirements and QSR expectations
  • Reviewing Supplier Quality Agreements for key elements
  • Performing and documenting Risk Assessment of Suppliers using the Total Risk Factor™

Order today and know how to implement procedures necessary to manage your suppliers and remain in compliance.

  • Quality assurance/quality control
  • Operations
  • Manufacturing
  • Materials management
  • Purchasing
  • Packaging and labeling
  • Plant engineering
  • Laboratory quality control
  • Regulatory affairs
  • Legal counsel
  • Engineering Managers
  • Quality Engineers
  • Production Engineers
  • Purchasing Managers
  • Purchasing Agents involved in outsourcing production or processes
  • Design Engineers
  • Project Managers involved in design and development

James Shore, Director of Quality Assurance/Regulatory Affairs, Titan Medical Inc.
James Shore is the Director of Quality Assurance/Regulatory Affairs at Titan Medical Inc. which is advanced robotic surgical technologies such as SPORT(TM) Surgical System.  Jim has 25 years of quality and supplier management experience working in medical devices, semiconductor, aerospace and defense (Lake Region, Nypro Healthcare, Boston Scientific, Aspect Medical, ACMI, Brooks Automation, and Raytheon). His professional certifications include ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Manager/Operations Excellence, Certified Quality Auditor and Certified Mechanical Inspector and ASQ Senior Member.