National Technical Reports Library

The National Technical Information Service acquires, indexes, abstracts, and archives the largest collection of U.S. government-sponsored technical reports in existence. The NTRL offers online, free and open access to these authenticated government technical reports. Technical reports and documents in its repository may be available online for free either from the issuing federal agency, the U.S. Government Publishing Office’s Federal Digital System website, or through search engines.

Details

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

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