Good Clinical Practice – Medical Device 11 Japanese PMDA GMP for Drugs

Japanese PMDA GMP for Drugs and Quasi-Drugs - 200

Over 300 pages of guidance and regulations to ensure your compliance is up to date

International Conference on Harmonisation Regulations

with over 900 pages of GMP Guidance and Regulations to ensure your compliance is up to date

Eudralex Pharmacovigilance for Medicinal Products for Human Use Volume 9a 8

Good Clinical Practice – Medical Device 11 Japanese PMDA GMP for DrugsGood Clinical Practices (GCP) Regulations for Medical Devices 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA 21 CFR and ICH Parts: 11 Electronic Records; Electronic Signatures 50 Protection of Human Subjects 54 Financial Disclosure by Clinical Investigators 56 Institutional Review Boards 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 812 Investigational Device Exemptions 814 Premarket