21 CFR 820 is applicable to manufacturers of finished medical devices sold in the United States, including foreign
manufacturers who import devices. Some manufacturers might be subject only to certain requirements, depending on the operations they are engaged in.
Medical device manufacturers that sell their products in the global market find it advantageous to get ISO 13485
certification because ISO standards are recognized worldwide. Certain countries require such certification. Many
customers also prefer medical devices that are ISO certified.
