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21 CFR Part 820 - Medical Device handbooks - More
Don't forget - You can mix and match parts!  Call for a free quote today! 856-810-7331
21 CFR Part 820 Quality Systems Regulations  $3.20 each  more...

Part 820 and Part 11 Electronic Systems  $5.95 each  more...

Part 820 with 210/211 Drug GMPs and Part 11  $6.90 each  more...

Part 820 with Part 58 GLP  $5.95 each  more...

Chinese Part 820 with US Part 820  $5.95 each  more...

Part 820 with Parts 11 and 58 GLP  $6.90 each  more...

Part 801 Labeling

Part 803 Medical Device Reporting

Part 806 Medical Devices; Reports of Corrections and Removal

Part 807 Estab. Reg. and Device Listing for Manuf. and Initial Importers...

Part 809 In-Vitro Diagnostic Products

Part 810 Medical Device Recall Authority

Part 812 Investigational Device Exemptions

Part 814 Premarket Approval of Medical Device

 

 

 

 

 
 
 

Other Medical Device handbooks in various combinations...
 
Standard Medical Device Combination Handbook -
                   21 CFR Parts 11, 50, 54, 56, 807, 812, 814, 820, PMA & 510k - $9.90 ea.

Parts 11 & 820 along with EU Directive 93/42/EEC. - $9.90 ea.

QSIT Manual with Part 820 - $6.90 ea.  Details

 QSIT Manual with Parts 11, 803, 806, 820 & 821 - $9.90 ea.  Details

Medical Device Quality Systems Manuals - Note: 5 book minimum
 530 pages of compliance quality initiatives for all companies operating under US GMP requirements...     More Details

Medical Device Quality Systems Manuals  $9.90 ea.   Details

Manual with 21 CFR Part 820 QSR   $11.90 ea.    Details

Manual with Part 820 & QSR Audit Check List  $13.90 ea.   Details

Manual with Parts 11, 210/211 & 820  $15.90 ea.   Details

Manual with Parts 11, 210/211, 820 & QSR Check List  $17.90 ea.  Details

Custom Med. Dev. Combo. Handbook 5 - 21 CFR Parts 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 820, PMA & 510k Guidance Document,  Canadian Medical Device Regulations, EU Medical Device Directive & Inspection of Medical Device Manufacturers 7382.845 - $29.95 each
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