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Note: This publication will be available in PDF format by June 18, 2020.
If you’re involved in any aspect of quality management systems (QMS) for your medical device, you need a strong change management process in place to avoid change interaction, where one change type triggers another change type.
Since QMS runs throughout your organization, it’s difficult to make a change in one area without impacting another.
Devicemaker’s Guide to Quality System Change Management breaks down QMS into separate areas where change may occur — device design, manufacturing processes, documentation and regulatory requirements. It explains the relevant requirements in the FDA’s quality management system regulations, the upcoming EU-MDR and the international standard ISO 13485. And it includes a template you can use to make sure each change element is properly addressed.
The report lays out a six-step plan for implementing change in the most cohesive way:
- Understand the difference between incremental change and step-shift change
- Identify change triggers
- Assess the business implications
- Ensure traceability through the steps of the change process
- Apply the process to specific change types
- Understand the interactions in the change types
Ensure a consistent approach to your change management process and avoid problems associated with ad hoc methods. Order your copy today.
Who Will Benefit
Managers and supervisors of the following functions would benefit:
- Design Engineering
- Regulatory Affairs
- Quality Management
- Risk Management
- Production
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ISBN-13:
978-1-60430-133-5
Publication date:
June 18, 2020
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