Harvest Dental Achieves ISO 13485 MDSAP Certification

Harvest Dental Achieves ISO 13485 MDSAP Certification

Harvest Dental Products is now certified to the latest global quality standard, ISO 13485 MDSAP (Medical Device Single Audit Program). This certification verifies that an organization meets or exceeds the stringent quality management requirements of the regulatory bodies in U.S., Canada, Europe, Brazil, Japan and Australia for medical device manufacturing.

To achieve this status, Harvest had to thoroughly document all its processes and then pass a comprehensive, four-day audit to demonstrate the effectiveness of its quality management systems. “Our team worked tirelessly for about seven weeks, documenting everything from purchasing to manufacturing, from assembly to final shipping. But, in reality, we’ve been working toward this certification for years, starting with the ISO 9001 certification we achieved in 2009,” says Stacey Putney, Director of Operations.

Elaborating on the company’s achievement, Founder and CEO Sasha Der Avanessian says, “ISO 13485 MDSAP is about a brand promise. First, it’s a promise to ourselves—it’s about integrity, conviction and the specific product legacy we want to leave behind. Then, of course, it’s a promise to our customers, whose distinct and positive experience with Harvest, whether a product or service, becomes the ultimate manifestation of that legacy.”

Founded in 2004, Harvest Dental has become one of the fastest growing consumable brands in the world and is now distributed in 60 countries. “Conceived to disrupt status-quo ways of thinking, we design charismatic and inspired products with a focus on being relevant, rather than preferred,” says Der Avanessian. To learn more, visit harvestdental.com.