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EL ISO 13485:2016 Medical devices — Quality management system
ISO 13485:2016 Medical devices — Quality management system What is ISO 13485:2016
ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It provides a framework for organizations to design, develop, produce, install, and service medical devices in a safe and effective manner.
Implementing an ISO 13485 can bring significant benefits to your organization. Here are some key benefits to keep in mind:
- Improved Product Safety and Effectiveness
- Enhanced Reputation
- Increased Competitiveness
- Regulatory Compliance
- Demonstrate Commitment
Why Work with Kriton Consultants?
At Kriton Consultants, we offer ISO 13485 consulting services to help organizations in the medical device industry achieve quality and safety in their products. Our team of experienced business consultants will work with you to understand your specific needs and develop a customized plan to help you achieve ISO 13485 certification. Achieving certification demonstrates to customers, suppliers, and other stakeholders that your organization is committed to producing high-quality medical devices that meet regulatory requirements.
Contact Us: If you’re interested in learning more about our ISO 13485 consulting services, please contact us today. Our team of experts is ready to help you achieve quality and safety in your medical devices and compliance with ISO 13485.
OUR ISO 13485 SERVICES
GAP Analysis
Awareness Training
Develop Policies and Procedures
Conduct Internal Audit
Identify Non-conformities
Conduct Management Review Meeting
Take Corrective Actions
External Audit
Monitoring the implementation of the System after the Certification
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ISO 27001 is a standard for information security management. It helps organizations protect sensitive information, enhance their security, and comply with regulations. We can help you implement ISO 27001 and optimize your information security practices. Contact us to learn more.
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Medical devices — Quality management system
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