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Documents, Change Control and Records - Food …

    https://www.fda.gov/media/118202/download
    General Requirements 820.180 Design History File 820.30(j) Device Master Record820.181 Document Controls 820.40 Device History Record 820.184 Quality System Record 820.186 Document...

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.180
    CFR - Code of Federal Regulations Title 21. 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 …

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 period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical …

eCFR :: 21 CFR Part 820 Subpart M -- Records

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-M
    § 820.180 General requirements. All records required by this part shall be maintained at the …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=58.195
    Subpart J - Records and Reports. Sec. 58.195 Retention of records. (a) Record retention requirements set forth in this section do not supersede the record …

Retention and Destruction of Health Information - AHIMA

    https://library.ahima.org/PB/RetentionDestruction
    To begin creating a record retention schedule, organizations and providers should use federal record retention requirements found within the Federal Register, …

eCFR :: 21 CFR Part 821 -- Medical Device Tracking …

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821
    (f) Device intended to be implanted in the human body for more than 1 year means a device that is intended to be placed into a surgically or naturally formed cavity of the human …

Record Retention for Device Manufacturers - OMBU Enterprises

    http://dev.ombuenterprises.com/wp-content/uploads/2019/03/Record_Retention_for_Device_Manufacturers.pdf
    Record Retention: Source: §803.18(c) Clock Starts: Date of the event Retention Period: The longer of <2 years> OR <a period of time equivalent to the expected life of the …

2022 Medical Records Retention Laws By …

    https://recordinglaw.com/medical-records-retention-laws-by-state/
    Oct 20, 2022

Medical Record Retention and Media Formats for Medical Records - HHS.gov

    https://www.hhs.gov/guidance/document/medical-record-retention-and-media-formats-medical-records
    Medical Record Retention and Media Formats for Medical Records. This is an informational article for physicians, non-physician practitioners, suppliers, and providers …



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