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Quality and Regulatory Information

With our robust quality management system and design control process, Drucker Diagnostics is committed to providing the highest quality clinical laboratory products to all of our current and potential business partners.

Drucker Diagnostics’ Quality Assurance and Regulatory team is available to coordinate with you to meet your regulatory needs. Whether you need a completed supplier quality survey or are in need of a technical or design file, we will provide you with the supporting documentation required to maintain compliance. Please see below for a full list of accreditations.

Accreditations

•  FDA Registered Facility
•  Quality Management System in place
•  Certified to ISO13485-2016 through BSI
•  Utilization of ISO 14971 Risk Management Process
•  Health Canada Licensed Products
•  EU Authorized Representative – Emergo Group

To reach our regulatory department, please email regulatory@druckerdiagnostics.com or use the contact form on this page. Our representatives can also be reached at +1-866-265-1486 (U.S. toll-free), Monday through Friday from 8:30 a.m. to 5:00 p.m. (Eastern Standard Time).

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