ISO 13485

Unlock Success in the Medical Device Industry

Ensure your company’s success in the Medical Device Industry by prioritizing ISO 13485 certification. From understanding the industry’s certification requirements to navigating the evolution from ISO 9001, Ledge Inc. offers comprehensive support. Let us guide your organization through document upgrades, system maintenance, and tailored internal audits, ensuring seamless compliance and fostering a culture of excellence.

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The 7 Principles of ISO 13485

1. Context of the Organization
Internal and External Issues as well as interested parties that support and define the organization’s scope.

2. Leadership
Top management provides leadership and direction for the organization by accepting and defining roles and responsibilities with an emphasis on quality and customer satisfaction.

3. Planning
Risks and opportunities should be considered when planning and changing the QMS.

4. Support
People, facilities and equipment that drive the QMS.

5. Operation
Implementing and maintaining processes necessary to provide products and services while managing risks and opportunities.

6. Performance Evaluation
Measure, monitor, analyze and consider the effectiveness and efficiency of the QMS processes.

7. Improvement
Identify opportunities to improve processes, products and services, to enhance customer satisfaction.

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