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Medical Device Quality Systems Manual: A Small Entity Compliance Guide. First Edition.


PB97148001

Publication Date 1996
Personal Author Lowery, A.; Strojny, J.; Puleo, J.
Page Count 320
Abstract This manual covers requirements of the Quality System regulation that manufacturers of medical devices must consider when they design devices, or when they manufacture, contract manufacture, remanufacture, process, repack, or relabel finished medical devices intended to be commercially distributed. The manual contains articles that explain the various good manufacturing practices (GMP) requirements such as design control, process validation, calibration, device master records, component control, etc., along with related topics such as labeling. It also contains examples of forms, procedures, decals, etc. Manufacturers may use this guidance when developing their quality system. The manual incorporates changes required by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992. This manual is an update of HHS publication FDA 91-4179, 'Medical Device Good Manufacturing Practices Manual. Fifth Edition.' This manual is used in the Division of Small Manufacturers Assistance (DSMA) medical device workshops.
Keywords
  • Medical equipment
  • Quality assurance
  • Compliance
  • Manuals
  • Regulations
  • Requirements
  • Flexibility
  • Manufacturers
  • Imported devices
  • Good Manufacturing Practices(GMP)
Source Agency
  • Office of Management and Operations
Corporate Authors Food and Drug Administration, Rockville, MD. Center for Devices and Radiological Health.
Supplemental Notes Supersedes PB92-111657.
Document Type Technical Report
NTIS Issue Number 199713
Medical Device Quality Systems Manual: A Small Entity Compliance Guide. First Edition.
Medical Device Quality Systems Manual: A Small Entity Compliance Guide. First Edition.
PB97148001

  • Medical equipment
  • Quality assurance
  • Compliance
  • Manuals
  • Regulations
  • Requirements
  • Flexibility
  • Manufacturers
  • Imported devices
  • Good Manufacturing Practices(GMP)
  • Office of Management and Operations
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