Design Change Analysis ? Five Considerations

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Category Medical Device

Deadline: July 20, 2015 | Date: July 20, 2015

Venue/Country: Online, U.S.A

Updated: 2015-06-30 16:30:12 (GMT+9)

Call For Papers - CFP

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.

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. This webinar explains the considerations you need to create a fully compliant system.

The first consideration is to 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 for 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 additional further classification.

The fifth consideration involves risk management. Companies implement ISO 14971:2007 and its associated Risk Management File. Every design change has the potential to revise the updated work. You need to evaluate any impact and update the hazard analysis and risk control measures.

This webinar explains the considerations and provides the information you need to stay in compliance.

Why you should attend:

This webinar provides the information you need for comprehensive and effective design change system that can help you avoid an FDA 483.

Areas Covered In the Webinar:

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

Who will 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

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of attendance