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Device History Record (DHR): An Overview

    https://www.qualitymeddev.com/2022/03/04/device-history-record/
    The device history record is a fundamental set of documentation that can be used within several processes of the quality management system of a company. First, it has a big impact on traceability since ti provides a full insight into the whole production …

CFR - Code of Federal Regulations Title 21 - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.184
    The information on this page is current as of Nov 29, 2022. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). …

What Is a Device History Record (DHR) and Why Is It Important?

    https://www.simplerqms.com/device-history-record/

    Design History File (DHF) vs. Device Master …

      https://www.greenlight.guru/blog/design-history-file-dhf-device-master-record-dmr-device-history-record-dhr
      The medical device industry has a lot of acronyms. The terms DHF, DMR, and DHR (which stand for Design History File, Device Master Record, and Device …

    A Breakdown of the FDA’s Medical Device …

      https://synectic.net/a-breakdown-of-the-fdas-medical-device-record-requirements/
      A well-maintained Device History Record can trace back each medical device to when, where, and how it was manufactured. If your organization uses a contract …

    Documents, Change Control and Records - Food …

      https://www.fda.gov/media/118202/download
      Device History Record 820.184. Quality System Record 820.186 . Document Controls 820.40. General Requirements 820.180. Quality System Record 40 • Maintain Quality …

    What Is Device Master Record (DMR) and Why Is It …

      https://www.simplerqms.com/device-master-record/
      The device master record is a regulatory requirement for all medical device companies. It is a repository of all essential information about your company’s medical …

    Device Master Record: Overview of FDA …

      https://www.qualitymeddev.com/2021/01/07/device-master-record/
      Device Master Record (DMR) and Medical Device File . The Medical Device File is a new requirement which has been introduced in the ISO 13485:2016.There …

    Device History Record (DHR) : PresentationEZE

      https://www.presentationeze.com/presentations/medical-device-validation/medical-device-validation-full-details/device-history-record-dhr/
      The “Device History Record”. The Device History Record (DHR) is outlined in the US FDA Quality System Requirements, Part 820, section 184. The FDA mandates that every …

    MDR - Regarding the “Retention Period” of Documents and Records

      https://elsmar.com/elsmarqualityforum/threads/mdr-regarding-the-%E2%80%9Cretention-period%E2%80%9D-of-documents-and-records.72576/
      This is regarding the “Retention Period” of Documents and Records as per ISO 13485, MDD, and also MDR. Please review below, provide suggestion in defining the …



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