Design Change Analysis - Five Considerations

Duration: 90 Minutes
Design changes are an important part of any medical device manufacturer's quality management system. It provides the mechanism to bring improved devices to market and fix problems with existing designs. Device manufacturers need an integrated system to handle design changes. In addition to the change itself, this system must include other parts of the regulations. If they apply, implement them. If not, create a quality record that explains the decision.This webinar explains these considerations and provides the information you need to stay in compliance.
Design Change Analysis
Instructor: Daniel O'Leary
Product ID: 501154
Objectives of the Presentation
  • The relationship among Design Output, Design Transfer, and Production Control
  • The reason why FDA could consider a Production Change as a Design Change
  • The elements of the new UDI rule including the Device Identifier (DI)
  • The triggers that create a new DI and to document your decision
  • The requirement to evaluate change significance for 510(k) purposes
  • Use of the 510(k) change guidance document to document your evaluation
  • Changes to the Risk Management File as a result of a design change
  • Implications for FDA Inspections
Why Should you Attend
This webinar explains what you need to do to implement a fully compliant system.

FDA QSR has a section on design changes, 820.30(i), that provides the basic requirements. Unfortunately, it does not provide all of the information necessary to satisfy practical considerations and FDA Regulations.

The first consideration is production and process changes. The FDA's inspection document (QSIT) tells Investigators that these changes are also design changes. The webinar explains the reasoning and provides tools for you to make this evaluation.

The second consideration is Unique Device Identification (UDI). In this rule, you must create a new Device Identifier, and load the database, for every change that creates a new version or model. The definition is open to allow manufacturers the flexibility to make good decisions based on their products. Every design change requires evaluation and a documented decision.

The third consideration is a significant change that would require a new 510(k). In this rule, you evaluate device changes to determine if the change could significantly affect the safety or effectiveness of the device. These changes include design, material, chemical composition, energy source, or manufacturing process. Every design change requires evaluation and the decision recorded. The FDA has a guidance document, published in 1997, that provides tools to help make this decision.

The fourth consideration involves corrections and removals. You need to classify each change as either an enhancement or a fix to a violation. You must report most fixes, which FDA will classify as a recall. Some, however, are exempt so you need to add further classification.

The fifth consideration involves risk management. An ISO 14971:2007 implementation requires a Risk Management File. Every design change has the potential to revise the file. You need to evaluate any impact and update the hazard analysis, the risk, and the risk control measures.

Who can Benefit
People in the following roles can especially benefit from the knowledge in this webinar:
  • Regulatory Managers
  • Recall Coordinators
  • Engineering Managers
  • Design Engineers
  • Quality Managers
  • Quality Engineers
  • Project Managers
  • Risk Managers
  • UDI Regulatory Contacts
  • UDI Coordinators
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Instructor Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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