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978-1-935131-28-1
Includes;

  • 21 CFR Parts 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 820
  • PMA & 510k Guidance Document,
  • Canadian Medical Device Regulations - December 2009
  • EU Medical Device Directive 93/42/EEC updated 2007/47/EEC
  • US FDA Inspection of Medical Device Manufacturers 7382.845
US EU Canadian Medical Device Combination