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英文字典中文字典相关资料:


  • eCFR :: 21 CFR Part 820 -- Quality System Regulation
    With respect to class I devices, design controls apply only to those devices listed in § 820 30 (a) (2) This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance
  • CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
    For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR) Note: If you need help accessing information in different file formats, see
  • 21 CFR §820 Quality System Regulation - Code of Federal Regulations
    PART 820 - QUALITY SYSTEM REGULATION Authority: 21 U S C 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U S C 216, 262, 263a, 264 Source: 61 FR 52654, Oct 7, 1996, unless otherwise noted
  • 21 CFR Part 820 - QUALITY SYSTEM REGULATION
    Subpart I—Nonconforming Product (§ 820 90) Subpart J—Corrective and Preventive Action (§ 820 100) Subpart K—Labeling and Packaging Control (§§ 820 120 - 820 130)
  • Pt. 820 21 CFR Ch. I (4–1–12 Edition) - GovInfo
    finished devices in-tended for human use The require-ments in this part are intended to en-sure that finished devices will be safe and effective and otherwise in compli-ance with the Feder l Food, Drug, and Cosmetic Act (the act) This part es-tablishes basic requirements applicable to
  • QSR (i. e. Current 21 CFR Part 820) QMSR (i. e. Future 21 CFR Part 820 . . .
    §820 30 Design controls §820 30 [Reserved] §820 35 Control of records In addition to the requirements of Clause 4 2 5 of ISO 13485 being applicable (i e Control of Records), manufacturers must include specific information in certain records, specifically: - Complaint records - Servicing records - Recording of UDI information
  • Medical Devices; Quality System Regulation Amendments 21 CFR 820
    FDA published the proposed amendment to 21 CFR Part 820: Medical Devices; Quality System Regulation Amendments, on February 23, 2022; harmonizing the current Quality System regulation for medical
  • FDA 21 CFR Part 820 Quality System Regulation: Definition . . . - SimplerQMS
    FDA 21 CFR Part 820 ensures the safety, effectiveness, and quality of medical devices across their entire lifecycle Structured across 15 subparts, the FDA 21 CFR Part 820 regulation addresses critical quality processes such as design control, production, document management, process validation, and complaint handling
  • Subpart A—General Provisions - GovInfo
    With respect to class I devices, design controls apply only to those de-vices listed in §820 30(a)(2) This regula-tion does not apply to manufacturers of components or parts of finished de-vices, but such manufacturers are en-couraged to use appropriate provisions of this regulation as guidance
  • eCFR :: 21 CFR Part 820 -- Quality System Regulation
    View the PDF for 21 CFR Part 820; These links go to the official, published CFR, which is updated annually As a result, it may not include the most recent changes applied to the CFR Learn more





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