Medical Device Guidelines and Regulations Handbook

Guidelines.- ISO 10993 – Biological Evaluation of Medical Devices.- ISO 22442 – Medical Devices utilizing Animal Tissues and Their Derivatives.- ISO 14971 & 24971 – Medical Device Risk Management.- ISO 21534 – Non-Active Surgical Implants – Joint replacement implants.- ISO 16061 Instrumentation for Use in Association with Non-Active Surgical Implants.- ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.- ISO 19227- Implants for Surgery – Cleanliness of Orthopedic implants.- ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects.- ISO 11607 - Packaging for Terminally Sterilized Medical Devices.- ISO 11137 -1, 2 and 3 - Sterilization of Health Care Products.- ISO 11135 - Sterilization of Health Care Products —Ethylene Oxide — Requirements for development, validation and routine control of a sterilization process for medical devices.- ISO 17665-1 - Sterilization of Health Care Products — Moist Heat.- Regulations.- FDA- CFR Title 21 - Food and Drugs: Parts 800 to 1299.- Global Medical Device Regulations (covering various individual countries).- EU 722/2012 – Animal Tissue Regulations in Effect for Some Medical Devices.- EU 2017/746 – In Vitro Diagnostic Medical Devices.- EU 1097/2006 - REACH.