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Quality
Quality
SanaVita Medical has an uncompromised dedication to quality. We understand the importance of quality to the success of your product and the welfare of your patients. We are an FDA registered contract manufacturer and have a quality management system that is compliant with
ISO 13485:2016.
Our Quality Policy:
We will consistently provide quality products and services to our business customers helping them to improve patients' quality of life. This will be achieved through customer focused and internally driven continuous improvement and maintaining an effective quality system which ensures our compliance with regulatory requirements and quality objectives.
FDA Registered Contract Manufacturer:
SanaVita manufacturers medical devices to its customer’s specifications
Maintains a quality system that complies with the requirements of 21 CFR Part 820 Quality System Regulation
Quality System is assessed by our customers during their supplier qualification process and can also be inspected by the FDA
Manufacturing occurs in ISO 7 class cleanrooms
Continuously monitors production processes to assure that critical to quality (CTQ) features established by its customer are assured
Creates unique device identification labels in accordance with customer specifications and applies them to the device packaging
Maintains records to assure compliance to customer and regulatory requirements
ISO 13485:2016 Certification:
Attained the ISO 13485:2016 certification under the scope of a contract manufacturer for medical devices
Quality Management System is assessed by a Notified Body on an annual basis
Quality Management System is assessed by customers during their supplier qualification process
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