Medica Holdings, LLC
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QUALITY


Medica Holdings Quality Policy Is Simple:
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Our job is to anticipate and meet our customers’ requirements, comply with applicable standards and regulatory requirements, and maintain the effectiveness of our quality management system through continuous improvement in every aspect of our business.

Medica Holdings, LLC's Quality Management System is fully compliant with the ISO 13485:2016 standards. We maintain the requisite procedures and controls to ensure our medical devices meet the international requirements for quality management systems in the medical device industry. We rigorously adhere to the principles and practices outlined in ISO 13485:2016. This commitment reflects our dedication to maintaining the highest levels of quality and safety in the design, development, production, and delivery of our products.

QUALITY MANAGEMENT SYSTEM
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ISO 13485:2016

PRODUCT CERTIFICATIONS AND APPROVALS

UNITED STATES
FDA 510(k) cleared/PMA approved devices
(Links to US FDA database device listing)
K172956


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