Course NameLengthAdvanced Risk Management for Medical Devices (ISO 14971:2019) Fundamentals2 daysAgile Medical Device Software Development Fundamentals2 daysASTM F1980: Accelerated Aging for Medical Device Shelf-Life Essentials2 daysASTM F2394: Particulate Testing for Medical Devices Essentials2 daysClinical and Quality Assurance Track: ISO 14155, ISO 19011, Design Controls, Process Validation Fundamentals2 daysClinical Investigation and ISO 14155 Essentials2 daysDesign Controls for Medical Device Development Training2 daysElectrical Safety for Medical Devices Essentials2 daysIEC 60601-1 — Electrical Safety and Essential Performance Training2 daysIEC 62304 — Software Life Cycle Processes for Medical Devices Fundamentals2 daysIEC 62366-1 — Usability Engineering for Medical Devices Essentials2 daysIntroduction to Working in the Medical Device Industry Fundamentals2 daysISO 10555: Standard for Intravascular Catheters (Including Balloon Catheters) Fundamentals2 daysISO 10993: Biological Evaluation of Medical Devices (Biocompatibility) Fundamentals2 daysISO 11135/11137: Sterilization of Medical Devices (EtO / Radiation) Fundamentals2 daysISO 11607: Packaging for Terminally Sterilized Medical Devices Essentials2 daysISO 13485: Quality Management Systems for Medical Devices2 daysISO 14155 — Clinical Investigation of Medical Devices for Human Subjects Essentials2 daysISO 14155: Clinical Investigation of Medical Devices Essentials2 daysISO 14971: Application of Risk Management to Medical Devices Essentials2 daysISO 15223-1: Symbols for Labeling and Packaging Fundamentals2 daysISO 19011 — Guidelines for Auditing Management Systems Training2 daysISO 20417: Information Supplied by The Manufacturer Fundamentals2 daysISO/TS 17012 — Conformity Assessment and Technical Competence2 daysISTA 2A/3A: Packaging and Distribution Testing Protocols Fundamentals2 daysMDR (EU Medical Device Regulation 2017/745) Essentials2 daysMedical Device Compliance MasterTrack: ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, MDR/IVDR, QSR Fundamentals2 daysMedical Software and Usability Track: IEC 62304, IEC 62366-1, IEC 82304-1, Agile Medical Software Fundamentals2 daysProcess Validation for Medical Devices Essentials2 daysProject Management for Product Development Essentials2 daysQSR — FDA Quality System Regulation (21 CFR Part 820) Essentials2 daysQuality Management and ISO 13485 Essentials2 daysRequirements Engineering for Medical Devices Essentials2 daysRisk and Safety Leadership Track: ISO 14971, Advanced Risk Management, Electrical Safety, Usability Fundamentals2 daysRisk Management and ISO 14971 Essentials2 daysUsability Engineering and IEC 62366-1:2020 Fundamentals2 days
