Course Name Length Advanced Risk Management for Medical Devices (ISO 14971:2019) Fundamentals 2 days Agile Medical Device Software Development Fundamentals 2 days ASTM F1980: Accelerated Aging for Medical Device Shelf-Life Essentials 2 days ASTM F2394: Particulate Testing for Medical Devices Essentials 2 days Clinical and Quality Assurance Track: ISO 14155, ISO 19011, Design Controls, Process Validation Fundamentals 2 days Clinical Investigation and ISO 14155 Essentials 2 days Design Controls for Medical Device Development Training 2 days Electrical Safety for Medical Devices Essentials 2 days Health Technology Product Development Workshop 2 days Human Factors Engineering for Medical Devices Workshop 2 days IEC 60601-1 — Electrical Safety and Essential Performance Training 2 days IEC 62304 — Software Life Cycle Processes for Medical Devices Fundamentals 2 days IEC 62366-1 — Usability Engineering for Medical Devices Essentials 2 days Introduction to Working in the Medical Device Industry Fundamentals 2 days ISO 10555: Standard for Intravascular Catheters (Including Balloon Catheters) Fundamentals 2 days ISO 10993: Biological Evaluation of Medical Devices (Biocompatibility) Fundamentals 2 days ISO 11135/11137: Sterilization of Medical Devices (EtO / Radiation) Fundamentals 2 days ISO 11607: Packaging for Terminally Sterilized Medical Devices Essentials 2 days ISO 13485: Quality Management Systems for Medical Devices 2 days ISO 14155 — Clinical Investigation of Medical Devices for Human Subjects Essentials 2 days ISO 14155: Clinical Investigation of Medical Devices Essentials 2 days ISO 14971: Application of Risk Management to Medical Devices Essentials 2 days ISO 15223-1: Symbols for Labeling and Packaging Fundamentals 2 days ISO 19011 — Guidelines for Auditing Management Systems Training 2 days ISO 20417: Information Supplied by The Manufacturer Fundamentals 2 days ISO/TS 17012 — Conformity Assessment and Technical Competence 2 days ISTA 2A/3A: Packaging and Distribution Testing Protocols Fundamentals 2 days MDR (EU Medical Device Regulation 2017/745) Essentials 2 days Medical Device Compliance MasterTrack: ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, MDR/IVDR, QSR Fundamentals 2 days Medical Device Security Risk Management Workshop 2 days Medical Software and Usability Track: IEC 62304, IEC 62366-1, IEC 82304-1, Agile Medical Software Fundamentals 2 days Process Validation for Medical Devices Essentials 2 days Project Management for Product Development Essentials 2 days QSR — FDA Quality System Regulation (21 CFR Part 820) Essentials 2 days Quality Management and ISO 13485 Essentials 2 days Regulatory and Quality Training for Medtech Workshop 2 days Requirements Engineering for Medical Devices Essentials 2 days Risk and Safety Leadership Track: ISO 14971, Advanced Risk Management, Electrical Safety, Usability Fundamentals 2 days Risk Management and ISO 14971 Essentials 2 days Usability Engineering and IEC 62366-1:2020 Fundamentals 2 days
