PDF/BSI Certificate FM 69288



Quality

At Millstone Medical Outsourcing, quality is our top priority. We understand that slips in quality can result in compromised care, recalls, and catastrophic business problems. Since the company began in 2000, Millstone has been deeply committed to operating under the highest quality standards, and our dedication to quality is in instilled in our professionals from senior management to our engineers to the office manager who answers the phone.

Our commitment to quality is evident in the extensive training we provide to our professionals, the attention to detail we employ in validation and testing procedures, and the capital investments we make in state-of-the-art facilities and equipment. We keep current with the ever-changing industry and utilize best practices in every aspect of our business. Our facilities are regularly audited by the Food and Drug Administration and our customers, and we continue to place a premium on improvements to processes and protocols. We believe in the importance of transparency and maintain careful records that are available for review. Just as the success of our customers lies in the quality of each product, we believe our success is based on our integrity and the trust our customers place in us as a strategic partner.

Certifications

Millstone is registered with the FDA and is ISO 13485 registered with BSI Management Systems. (ISO, International Organization for Standardization, is the world’s largest developer and publisher of international standards.) The ISO 13485 registration is a specific designation for medical devices. In addition, the Memphis, TN, facility is registered with the FDA as a human tissue bank and is registered and licensed to store and distribute human tissue and bone products in a variety of states across the country.