Design Controls 820.30 & ISO 13485 § 7.3 (Executive Series #9)

Design Controls 820.30 & ISO 13485 § 7.3 (Executive Series #9)Подробнее

Design Inputs 820.30c & ISO 13485 § 7.3.3 (Executive Series #12)Подробнее

Risk Management 820.30g & ISO 13485 § 7.1, 7.3.3, & 7.3.9 (Executive Series #21)Подробнее

Design Validation 820.30g & ISO 13485 § 7.3.7 (Executive Series #16)Подробнее

Design control for medical devices - what is it and why you should do itПодробнее

Personnel & Training 820.25 & ISO 13485 § 6.2 (Executive Series #8)Подробнее

Design Planning 820.30b & ISO 13485 § 7.3.2 (Executive Series #11)Подробнее

Design Review 820.30e & ISO 13485 § 7.3.5 (Executive Series #14)Подробнее

Design Changes 820.30i & ISO 13485 § 7.3.9 (Executive Series #18)Подробнее

Design Controls General Requirements 820.30a & ISO 13485 § 1 & 7.3.1 (Executive Series #10)Подробнее

Design Transfer 820.30h & ISO 13485 § 7.3.8 (Executive Series #17)Подробнее

Traceability 820.65 & ISO 13485 § 7.4.2 & 7.5.9 (Executive Series #30)Подробнее

Nonconforming Product 820.90 & ISO 13485 § 8.3 (Executive Series #44)Подробнее

Acceptance Activities 820.80a-d & ISO 13485 § 7.1, 7.4.3, 7.5.10, 8.2.6 (Executive Series #42)Подробнее

FDA's Transition from CFR 820 to the ISO 13485:2016 Instituting a New QMSПодробнее

Design Verification 820.30f & ISO 13485 § 7.3.6 (Executive Series #15)Подробнее

Process Changes 820.70b and ISO 13485 § 4.1.4, 4.2.4, 7.3.9, 7.4.3, 7.5.6 (Executive Series #32)Подробнее

Design Outputs 820.30d & ISO 13485 § 7.3.4 (Executive Series #13)Подробнее

Process Development 820.30h, 820.75, & ISO 13485 § 7.3.8 & 7.5.6 (Executive Series #69)Подробнее