ISO-AID CAN ASSIST YOU WITh the IMPLEMENTATION AND MAINTENANCE OF A QUALITY SYSTEM

QUALITY IS ALWAYS FIRST 

In addition to the 9001 Quality Standard, 13485 Medical Device, and AS9100D Aerospace, there are other quality standards a company might need to comply with.

For medical device companies selling to Canada, a MDSAP certification is required for all products above Class I. For sales of product to the European Union, a CE mark is required that shows compliance to the European Medical Device Directive. As of this date, the MDD is transitioning to the Medical Device Regulation.


Federal Drug Administration

FDA

Medical devices sold in the United States must comply with the 21 CFR part 820, Quality System, and relevant parts 803, 806, 807, and 821.


EUROPEAN COMMISSION

mEDICAL DEVICE DIRECTIVE 93/42/ECC

Used by companies which design, develop, or provide aviation, space, and defense products and services. Further information can be found on OASIS, The Online Aerospace Supplier System

medical device regulation 2017/745

Used by companies which design, develop, or provide aviation, space, and defense products and services. Further information can be found on OASIS, The Online Aerospace Supplier System