21 cfr part 820 iso 13485 July 8, 2019 16 32 64 128 21 cfr part 820 vs iso 13485 Fda 21 cfr part 820 iso 13485 Comparison between iso 13485 and 21 cfr part 820 (21 cfr part 820 21 cfr part 820.30 21 cfr part 820 subpart c