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Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).
Instructors: Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. ..more John E Lincoln Consultant, Medical device and Regulatory affairs John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures. ..more Edwin L Bills Principal Consultant, Bilanx Consulting LLC During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. ..more Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. ..more Albert Cefalo Regulatory Affairs Specialist, Analogic Corporation Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University...more
DHF, DMR, DHR, Technical File and Design Dossier Key Requirements and Future Directions
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
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