OpenRegulatory
Learn about developing Software as a Medical Device without setting your hair on fire.
Free Course: Understanding Unique Device Identifiers (UDIs) For Medical Devices
Software Validation (ISO 13485 QMS), Part 2
Software Validation (as part of your QMS, for the ISO 13485)
Purchasing: Supplier Checklist For ISO 13485 Compliance
Purchasing SOP For Medical Devices (ISO 13485)
Human Resources Administration For Medical Device Companies (ISO 13485)
Vigilance For EU MDR and ISO 13485 Compliance
CAPAs (Corrective and Preventive Actions) For ISO 13485 Compliance
EU MDR Post-Market Surveillance, Part 2 (+ ISO 13485)
EU MDR Post-Market Surveillance, Part 1 (+ ISO 13485)
Feedback Management For Medical Device (ISO 13485) Compliance
Internal Audits (ISO 13485 Compliance)
Management Reviews For ISO 13485 Compliance (Medical Devices)
Certification and Product Registration Process
Document and Record Control For The ISO 13485
Free Course: Quality Management For Medical Devices (ISO 13485 QMS)
Usability Evaluation Plan & Report (Finalizing Medical Device Usability Compliance - IEC 62366)
Formative Evaluation For Usability Compliance (IEC 62366 For Medical Devices)
Doing the Summative Usability Evaluation (User Tests Medical Device Compliance - IEC 62366)
Medical Device Usability Engineering: Writing User Tests (Summative Evaluation of IEC 62366)
Free Usability Engineering Course (Medical Devices - IEC 62366)
ISO 14971 Wrap-Up: Sanity Check, AI Descriptions, Risk Management Plan & Report
No One Does Preliminary Hazards Analysis (Mostly) (ISO 14971 Medical Device Risk Analysis)
Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering)
Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)
Risk Controls Make Your Life Easier (Medical Device Risk Management)
Medical Device Failure Modes (ISO 14971 Risk Analysis)
Risk Tables Are Easy (Medical Device Risk Analysis, ISO 14971)
Medical Device Risk Analysis: Risk Matrix (ISO 14971)
Free Medical Device Risk Management Course: Introduction & Simple Risk Table (ISO 14971)