Certifications

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ISO 13485:2016

Endoch Medical has achieved ISO 13485:2016 certification, which is a globally recognized standard for quality management systems specific to the medical device industry. 
This certification ensures that Endoch Medical’s products consistently meet customer and regulatory 
requirements, demonstrating our commitment to quality and continuous improvement.

Medical Device Single Audit Program (MDSAP)

Endoch Medical is also certified under the Medical Device Single Audit Program (MDSAP). This certification allows us to meet the regulatory requirements of multiple international markets, including the United States, Canada, Australia, Japan, and Brazil, through a single audit of our quality management system. This program streamlines compliance and increases access to global markets.

FDA Certification

 

Endoch Medica’s full product line is 100% FDA-certified, allowing even more customers to enjoy the largest medical devices product catalogue in the North American market. Our products go where you go.